Atrial Septal Occluders

An Atrial Septal Defect (ASD) is a birth defect of the heart characterized by an opening between the left and right atria that failed to close after birth.  People suffering from an ASD typically have low blood oxygen levels, due to deoxygenated blood passing through the opening in the heart and mixing with oxygen rich blood before being pumped to the rest of the body.  An ASD may be treated with the implantation of an “Amplatzer” Atrial Septal Occluder (ASO).  Implanting an ASO is a fairly simple procedure, and doesn’t require major surgery.  On rare instances, ASOs may erosion and/or change shape.  These changes can cause severe complications, which may be fatal if not treated promptly.

Many studies have set out to explore the factors leading up to these complications, hoping to reduce future complications.  A 2009 study titled “The influence of morphological changes in amplatzer device on the atrial and aortic walls following transcatheter closure of atrial septal defects,” was conducted by Kitano et al. and published in the Journal of Interventional Cardiology in 2009.  The purpose of the study was to analyze physical changes in the ASO after implantation and investigate how they affect the surrounding tissues.  The authors stated “This study prospectively investigated morphological changes in Amplatzer Septal Occluder (ASO) over time and the influences of these changes on the atrial and aortic walls after atrial septal defect (ASD) closure.”

The study included 78 patients with ASD, who had been treated with an ASO.  Any changes in the shape, thickness, and relations to the atrial or aortic walls were evaluated at different points in time.

The researchers documented decreases in the ASO thickness, changes in the ASO’s location and shape.  The author’s stated “As the device becomes thinner, loses its flexibility, and often changes from a flare-to-closed shape on the aortic side over time, the edges of ASO can start to compress the atrial and aortic walls. However, erosion was not recognized in these cases.”

Because ASOs have been found to fail and/or erode in many patients, as documented by a number of research studies, Amplatzer ASO lawsuits are being filed across the country.  If you or a loved one used an amplatzer (especially one manufactured by St. Jude), you may be entitled to significant financial compensation through an amplatzer ASO lawsuit.  For more information, feel free to contact our team of ASO lawyers at your convenience

(855) 452 – 5529

justinian@dangerousdrugs.us

We have the skills, resources, and experience required to win the justice you deserve.  Call today and see how we can help!  Our Amplatzer ASO Lawsuit Information page is a great place to start if you have any questions about ASOs.

Atrial Septal Defect (ASD) is a condition of the heart in which there is an opening between two chambers of the heart, which failed to close after birth.  As a result, the blood pumped through the body has abnormally low levels of oxygen.  One treatment for this condition employs the use of an Atrial Septal Occluder (ASO), which seals the opening between the two chambers.  One of the advantages of ASO usage is that it is minimally invasive, and doesn’t require surgery; the device is implanted through a vein.  ASO usage has unfortunately led to numerous complications due to erosion after implantation.  In many cases these complications can be fatal if left untreated.

Many studies have been conducted to assess the safety of ASOs.  One such study was conducted by Crawford et al. and published in Medline.  The title of the study is “Percutaneous atrial septal occluder devices and cardiac erosion: a review of the literature,” with the stated objective being “to systematically review all cases in the literature of erosion associated with atrial septal defect (ASD) occluder devices.”

There have been several reports of erosion associated with implantation of this device.  According to this study, calculating the statistical likelihood of erosion occurring post-implantation is not currently possible due to an unknown number of implantations and an unknown number of reported complications.  However, the estimated likelihood of erosion is under 1%.

In this study, the authors concluded, “Cardiac erosion is a rare but serious complication of the ASO device. Erosion events are most often ascribed to device over-sizing or deficient retro-aortic rims; however, both consensus and evidence for a cogent risk factor(s) is lacking.”  The authors stated that the causes of these complications have yet to be determined and that further research must be conducted.

Because so many people have used amplatzers but were unaware of the risk for erosion associated with ASOs, many ASO erosion lawsuits have been filed.  If you or a loved one used an ASO and experienced amplatzer side effects, you may be entitled to significant financial compensation for the injuries suffered through no fault of your own.

For more information, please do not hesitate to contact our team of ASO lawyers at the information provided below.  We have the skills, resources, and experience required to win the justice you deserve, even from the largest of medical device manufacturers.  Call today and see how we can help!

(855) 452 – 5529

justinian@dangerousdrugs.us

Our Amplatzer ASO Lawsuit Information page is a great place to start if you have any questions about ASOs.

An atrial septal defect (ASD) is a condition of the heart characterized by an opening that failed to close after birth.  The opening is located between the left and right atria, which are two of the four chambers in the heart.  When the opening between these chambers exists it allows de-oxygenated blood to mix with oxygenated blood before being pumped to the rest of the body.  This may result in insufficient oxygen being delivered to the rest of the organs.  One treatment for this condition involves using an “Amplatzer” Atrial Septal Occluder (ASO).  The ASO is implanted into the heart, and seals the opening between the two atria, without performing major surgery.  Complications due to erosion are rare, however they may be fatal if not treated promptly.

Instances of complications have been reviewed and guidelines regarding ASO implantations have been revised based on these reviews.  HG El-Said and JW Moore conducted a study published in a 2009 edition of the Journal of Catheterization and Cardiovascular Interventions, titled “Erosion by the Amplatzer septal occluder: experienced operator opinions at odds with manufacturer recommendations?”  The authors state, “The aim of our study is to help define an expanded expert consensus with respect to the causes and preventive strategies for erosions.”  In this report, the researchers analyzed the results from an ASO implantation case study that closely followed the expert’s guidelines in addition to a survey of the Congenital Cardiovascular Interventional Study Consortium collecting the opinions and experiences from experts who have used ASOs.

The survey reported 14 total erosions out of 3,010 implants.  Deficit aortic rims were observed in 90% of erosions.  Other factors that increased the rate of erosion were undersized devices that do not straddle the aorta and motion of the device relative to the heart.

The authors concluded “Both the survey results and our single case experience suggest that operator opinions (and perhaps also device sizing practices) are at odds with the 2004 revisions.   While the authors purport that further study and focus on this issue is needed, many people have experienced the negative side effects of ASO use already.

Due to the fact that St. Jude, a large medical device manufacturer that makes many ASO devices, has failed time and again to warn the public of the risks associated with ASOs, a number of St. Jude Amplatzer lawsuits have been filed.  If you or a loved one used an ASO an experienced one of these negative side effects, you may be entitled to significant financial compensation for the injuries you sustained through no fault of your own.

For more information on Amplatzer lawsuits or a free, no-obligation case consultation, contact our team of Amplatzer lawyers at the information provided below.  We have the skills, resources, and experience required to win the justice you deserve.

(855) 452 – 5529

justinian@dangerousdrugs.us

Call today and see how we can help!  Our Amplatzer ASO Lawsuit Information page is a great place to start if you have any questions about ASOs.

An Atrial Septal Defect (ASD) is a cardiac malformation, in which an opening between chambers in the heart did not properly close following birth.  This can be very problematic because it lowers oxygen levels in the blood; this happens as a result of oxygen deficient blood mixing with oxygen rich blood before being pumped out to the rest of the body.  One treatment involves using an “Amplatzer” Atrial Septal Occluder (ASO).  Implanting an ASO is a minimally invasive procedure, as the device is placed through a vein and does not require major surgery.  At the same time, there have been some instances of serious complications.  These complications can be fatal if not treated promptly.

Many studies have been conducted to analyze the risk factors involved with such cases.  One such study (published 2004) titled “Erosion of Amplatzer septal occluder device after closure of secundum atrial septal defects: review of registry of complications and recommendations to minimize future risk,” was conducted by Amin et al. and published in the Journal of Catheterization and Cardiovascular Interventions.  The authors stated “The objectives of this study were to identify possible risk factors that may lead to erosion of the Amplatzer septal occluder (ASO) and recommend ways to minimize future risk.”

Instances of adverse events after ASO placement are quite rare.  Identifying common factors of high risk cases may allow for early recognition of complications and prompt intervention could minimize the frequency of adverse outcomes.  In this study, echocardiograms, ASD size, size of the device used, cineangiograms, and operative records were collected from cases in which complications developed.  These factors were reviewed and analyzed to determine which most commonly occurred in patients who suffered from complications.

The authors of the study concluded “Patients with deficient aortic rim and/or superior rim may be at higher risk for device erosion. Oversized ASO may increase the risk of erosion. The defect should not be overstretched during balloon sizing.”  While complications are rare, incidences can be decreased by identifying high-risk patients and following them closely after placement of the ASO.

Because many people have experienced these rare but serious side effects of ASO use, a number of Amplatzer lawsuits have been filed.  If you or a loved one used an amplatzer, particularly those manufactured by St. Jude, you may be entitled to significant financial compensation for your injury.

For more information on amplatzer lawsuits, or a free, no-obligation ASO lawsuit consultation, please do not hesitate to contact our team of ASO lawyers at the information provided below.

(855) 452 – 5529

justinian@dangerousdrugs.us

We have the experience, resources, and skills required to win the justice you deserve.  Call today and see how we can help!  Our Amplatzer ASO Lawsuit Information page is a great place to start if you have any questions about ASOs.

Atrial Septal Defect (ASD) is a rare malformation of the heart in which there is an opening between two chambers of the heart.  Typically, this opening closes after birth; ASD is when the opening fails to close.  As a result, people with ASD have abnormally low blood oxygen levels because blood oxygen rich blood is mixing with low oxygen blood.  One treatment for this condition employs the use of an Atrial Septal Occluder (ASO), which seals the opening between the two chambers. ASO implantation is minimally invasive, and doesn’t require major surgery because the device is implanted through a vein.  ASO usage has unfortunately led to numerous complications because of erosion after implantation.  These complications can be fatal if they are not treated on time.

Studies have set out to explore the risk factors associated with ASO usage.  One study titled “Echocardiographic predictors of cardiac erosion after amplatzer septal occluder placement” was conducted by Amin Z, and published in Pubmed.  The two factors that appear to cause complications are Aortic rim deficiency and the use of over-sized ASOs.  The author states that this study “attempts to describe device characteristics, anatomical features and echocardiographic predictors that increase the risk of erosion.”

This study included 12 new cases and evaluated a number of parameters that could have potentially caused complications such as ASD location (high or low), rims deficiency and consistency, septal mal-alignment, dynamic nature of the defect; device edge relationship toward the transverse sinus (TS), atrial free wall tenting and the size of the defect compared with the size of the device used for closure.

The results of the study showed that multiple factors did in fact contribute to complications.  “Aortic rim absence in multiple views, poor posterior rim consistency, septal mal-alignment, and dynamic ASD appear to be factors where erosion risk increases significantly.”  The author also states that the 26-mm device had the highest rate of erosion.

Due to the fact that many people have used amplatzer devices manufactured by St. Jude unaware of the risk for erosion associated with ASOs, a number of St. Jude Amplatzer ASO lawsuits have been filed.  If you or a loved one has used an ASO and experienced negative amplatzer side effects, please do not hesitate to contact our team of amplatzer ASO lawyers at the information provided below.

(855) 452 – 5529

justinian@dangerousdrugs.us

We have the skills, resources, and experience required to win the justice you deserve.  Our Amplatzer ASO Lawsuit Information page is a great place to start if you have any questions about ASOs.

Many treatments have been created to remedy Atrial Septal Defects (ASD).  An ASD is a condition of the heart characterized by an opening between the left and right atria.  This opening between the two heart chambers can lead to low blood oxygen levels, as deoxygenated blood is not properly kept separated from oxygen rich blood before being pumped to the rest of the body.  One treatment for an ASD employs the use of an atrial septal occluder.  An occluder can be placed in the heart to seal the opening, without performing major surgery.  Complications have been reported following the implantation of an occluder to treat an ASD.  One common complication is a result of embolization due to aortic rim erosion.

Many studies have been conducted to identify risk factors of embolization and erosion.  One study conducted by M Misra et al. was published in The Journal of Interactive Cardiovascular Thoracic Surgery in 2007, and is titled “The ‘aortic rim’ recount: embolization of interatrial septal occluder into the main pulmonary artery bifurcation after atrial septal defect closure.”  In this case study the authors report a “rare complication of early embolization of the Blockaid septal occluder into the main pulmonary artery bifurcation associated with ‘aortic rim’ erosion”.  Furthermore the report provides additional information on complications associated with aortic rim erosion.

The case study reports a procedure performed on an 18 year old male, in which a septal occluder was successfully placed.  The study reports that the day after the procedure the participant had embolization of the device into the main pulmonary artery bifurcation. Emergency surgical retrieval of the device with closure of the ASD was performed.  At surgery the ASD was found to have an eroded aortic rim.

In their conclusion the researchers stated that the complications were due to “a combination of factors including an inadequate aortic rim; a grossly oversized device which eroded the aortic rim; and the Blockaid septal occluder, whose formally untested design and configuration could have led to its migration.”  They concluded that incidences of complications could be reduced with proper evaluation of the aortic rim, proper device size, and choice of the device.

Studies like this illustrating the danger of ASOs can be used in an ASO lawsuit to demonstrate to a court that the manufacturer of this device knew, or should have known, that its product was associated with cardiac erosion.

If you or a loved one used an ASO and suffered cardiac erosion or another atrial septal occluder side-effect, you may be entitled to significant financial compensation from the manufacturer of the device you used.  Many studies have been published on this subject and it is clear that these medical device companies ought to have been aware of the risks associated with their products.

For more information, or for a free, no-obligation ASO lawsuit consultation, contact our team of ASO lawyers at your convenience.  We have the experience, skills, and resources required to win the justice you deserve, even from the largest of medical device manufacturers.  Call today and see how we can help!

(855) 452 – 5529

justinian@dangerousdrugs.us

Our Amplatzer ASO Lawsuit Information page is a great place to start if you have any questions about ASOs.

An Atrial Septal Defect (ASD) is a cardiovascular birth malformation.  The condition is characterized by an opening between two chambers of the heart, the left and right atria.  This opening closes after birth in healthy individuals but may fail to close for others, thus forming an ASD.  An ASD is problematic because it causes low blood oxygen levels due to deoxygenated blood passing through the opening, and mixing with oxygen rich blood before being pumped out of the heart.  The condition may be treated with an Amplatzer Septal Occluder (ASO), which seals the opening without requiring major surgery.  ASO’s have been effective in treating the defect, but there have been a number of reports of complications after implantation.  One major issue that has caused complications is selection of the proper size of the device.

One study that set out to investigate more about ASD sizing was conducted by M Zanchetta and published in The International Journal of Cardiology in 2004.  The study is titled “On-line intracardiac echocardiography alone for Amplatzer Septal Occluder selection and device deployment in adult patients with atrial septal defect.”  The author stated “For the Amplatzer Septal Occluder (ASO) device, accurate balloon sizing is considered of paramount importance because the prosthesis waist has to be exactly adjusted to the defect diameter (+/-1 mm).”  (Hyperlink added.)

The purpose of this study was to explore the effectiveness of different sizing techniques, and to evaluate the consequences of using an improperly-sized ASO: “In this study, we aimed to demonstrate the possibility of marked misinterpreting of the actual defect size using the balloon technique in patients with secundum ASD and to evaluate the accuracy of intracardiac echocardiography (ICE) measurements.”

The study included 166 patients who underwent percutaneous transvenous secundum ASD occlusion using the ASO device, while an additional 124 ASD closures were performed using conventional methods.  The results showed that successful implantation was accomplished in 163 out of 166 patients.  Successful occlusion was demonstrated in 92.2% of ASO procedures.

In my opinion, a failure rate of 7.8% is too high.  That aside, what is more important is that patients be aware of the risks associated with any and all medical procedures executed on their behalf.  Due to the fact that many people have undergone Amplatzer ASO operations unaware of the risk for cardiac erosion associated with the Amplatzer device, a number of Amplatzer lawsuits have been filed against the manufacturer, St. Jude Medical, Inc..  Many peer-reviewed scientific studies have demonstrated that cardiac erosion can occur with the Amplatzer, but St. Jude has not made this risk clear to patients.

If you or a loved one used an ASO, or the Amplatzer ASO by St. Jude, and suffered cardiac erosion or another ASO side-effect, you may be entitled to financial compensation from the manufacturer of your device.  For a free, no-obligation case consultation, contact our team of Amplatzer ASO lawyers at the information provided below.

(855) 452 – 5529

justinian@dangerousdrugs.us

Our Amplatzer ASO Lawsuit Information page is a great place to start if you have any questions about ASOs.

An Atrial Septal Defects (ASD) is a cardiovascular condition characterized by an opening in the heart.  The opening is located within the septum, which separates the left and right atria of the heart.  An ASD occurs when the opening fails to close after birth, and is associated with low blood oxygen levels.  This is a result of de-oxygenated blood passing through the opening and mixing with oxygen rich blood before being pumped out to the rest of the body.  One treatment for ASD involves using an Atrial Septal Occluder (ASO), commonly, the “Amplatzer” device, by St. Jude Medical, Inc..  The ASO seals the opening and can be implanted without major surgery.  Several cases have been reported involving complications after implantation of an ASO.

Many studies have been conducted to evaluate the effectiveness of ASO implantation, as well as the risk factors involved.  One such study was conducted by M Behjati et al. and is titled “Transcatheter closure of atrial septal defect with amplatzer septal occluder in adults: immediate, short, and intermediate-term results,” published in the Journal of Tehran Heart Center in 2011.  The authors stated “The transcatheter closure of the atrial septal defect (ASD) has become an alternative technique to surgical procedures. The aim of this study was to assess the immediate, short, and intermediate-term results of the transcatheter closure of the secundum ASD with the Amplatzer Septal Occluder (ASO) in adult Iranian patients.”

The study involved ASO implantation in 58 adult patients.  Follow-ups included physical examination, electrocardiography, and transthoracic echocardiography, these were conducted at one month, six months, and annually.  Successful deployment of the ASO was observed in 89.6% of patients and failed in the remaining 10.4%.  Four patients experienced severe complications.  The researchers concluded that ASO’s are associated with a relatively high success rate, but are still subject to complications.  The authors stated “The use of this device, however, requires thorough attention in that the procedure may be ineffective or the device may embolize. Further experience and long-term follow-up are required before a widespread clinical use can be recommended.”

Due to the fact that a number of patients have used ASOs unaware of the risk for cardiac erosion associated with Amplatzer devices, a number of Amplatzer ASO lawsuits have been filed against St. Jude, the manufacturer of the Amplatzer.  If you or a loved one used an ASO and suffered cardiac erosion as a result, you may be entitled to significant financial compensation.

For more information, or for a free, no-obligation Amplatzer lawsuit consultation, contact our team of Amplatzer lawyers at your convenience.  We have the experience, resources, and skills required to win the justice you deserve.  Call today and see how we can help!

(855) 452 – 5529

justinian@dangerousdrugs.us

Our Amplatzer ASO Lawsuit Information page is a great place to start if you have any questions about ASOs.