MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Device Problem Biocompatibility (2886)

Patient Problem Cardiac Tamponade (2226)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, tamponade was seen in 23 patients between 1998 and 2004.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

The article "two cases of pericardial tamponade due to nitinol wire fracture of a gore septal occluder" was reviewed.This article was a meta-analysis of studies involving atrial septal occluders.The article made reference to a safety communication titled "food and drug administration.St jude amplatzer atrial septal occluder (aso): safety communication: reports of tissue erosion" between 1998 and 2004, 23 patients with pericardial tamponade were reported to aga medical (abbott).The paper concluded that a deficient aortic or superior rim and use of an asd device whose diameter is 2 mm greater than the balloon-stretched diameter of the asd increased the risk of device erosion.The primary author is preetham kumar, md, of division of cardiology, department of medicine, university of california, los angeles, los angeles, california.The corresponding email is: preethamkumar@mednet.Ucla.Edu.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10320583
• MDR Text Key: 201016170
• Report Number: 2135147-2020-00307
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/01/2020
• Initial Date FDA Received: 07/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention