St. Jude Amplatzer Atrial Septal Occluder: Reports of Tissue Erosion

St. Jude Amplatzer Atrial Septal Occluder (ASO): Reports of Tissue Erosion

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The FDA informs cardiology health personnel and patients that, in rare cases, the tissue around the Amplatzer Atrial Septal Occluder may erode and may cause life-threatening emergencies.

St. Jude Amplatzer Atrial Septal Occluder, ASO, Tissue Erosion,

Background of St. Jude Amplatzer Atrial Septal Occluder (ASO)

The St. Jude Amplatzer Atrial Septal Occluder is a cardiac implant device for the treatment of an abnormal hole in the heart, the atrial septal defect (ASD). This metal device is inserted into a vein through a catheter, and it is considered as alternative to open heart surgery.

FDA Alert on St. Jude Amplatzer Atrial Septal Occluder (ASO)

In rare instances, the device rubbing against the wall of the heart can erode the tissue and create a hole. In addition, it may cause simultaneous holes in the aortic root. If too much blood builds up in the sac surrounding the heart, the heart may not work properly.

FDA Recommendation on St. Jude Amplatzer Atrial Septal Occluder (ASO)

“Healthcare professionals should review the updated Instructions For Use (IFU) for the Amplatzer ASO before implanting the device. Consider the potential for erosion when talking to patients about long- and short-term benefits and risks of treatment options, including implantation with the Amplatzer ASO. Educate patients implanted with the Amplatzer ASO to seek immediate medical attention if they develop symptoms such as chest pain, numbness, sudden weakness, dizziness, fainting, shortness of breath, or rapid heartbeat.

The FDA does not recommend device removal for patients who have the Amplatzer ASO unless physicians determine it is appropriate for their particular patient(s). The risks associated with device removal surgery may be equal to or greater than the risk of erosion. See the FDA Device Safety Communication for additional information and recommendations.”

Contacting the FDA to report cases with St. Jude Amplatzer Atrial Septal Occluder (ASO)

In case of detection of adverse events or side effects related to the use of St. Jude Amplatzer Atrial Septal Occluder (ASO), healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

  • The report can be completed and submitted Online at: www.fda.gov/MedWatch/report.htm
  • The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form
  • The completed form can be faxed to: 1-800-FDA-0178

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