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

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Mitral Regurgitation (1964)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, an amplatzer device was explanted four years after implant due to the mitral valve leaflet hitting the edge of the device, causing mitral regurgitation.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported through a research article identifying a 32mm amplatzer occluder that may be related to explant two years post implant.The 32mm amplatzer device was successfully implanted.Two years post implant, the patient developed an apical systolic murmur grade 2/6.No shunt was detected and the device appeared in place, however, in the early systolic phase, the base of the anterior mitral leaflet seemed to collide with the inferior edge of the device.By four years post-implant, mitral regurgitation (mr) had increased to severe and it was decided to perform surgical intervention.Surgical inspection revealed the presence of diffuse prolapsed anterior mitral leaflet.Repair was accomplished through direct suture concomitant with removal of the amplatzer device and atrial septum closure with a competitor's gore-tex cardiovascular patch.Specific patient information is documented as unknown.Details are listed in the attached article, titled "images of mitral valve perforation due to atrial septal occluder device".

• Brand Name: AMPLATZER OCCLUDER (UNKNOWN)
• 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: 9649687
• MDR Text Key: 178353454
• Report Number: 2135147-2020-00018
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/30/2020

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: 01/09/2020
• Initial Date FDA Received: 01/30/2020
• 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): Required Intervention
• Patient Age: 22 YR