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

Model Number CVD0099

Device Problems Migration or Expulsion of Device (1395); Biocompatibility (2886)

Patient Problem Complete Heart Block (2627)

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

It was reported through a research article titled "long-term performance after interventional vsd closure¿single center experience in pediatric and adult patients" that 196 catheterization procedures were performed between 1993 and 2018.The implanted devices included amplatzer membranous or muscular vsd occluder (116), nit-occlud lê vsd (24), amplatzer duct occluder ii (19), amplatzer duct occluder i (19), lifetech konar mfo (8), and other devices (10).The complications reported included one device explant due to complete atrioventricular block four days post procedure, and 4 of the 196 devices were removed due to dislocation.It was not reported what devices were associated with these complications.No additional information could be obtained.

Manufacturer Narrative

Additional information: h6, h10.Events of atrioventricular block and 'dislocation' were reported in a research article.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.

• Brand Name: AMPLATZER MEMBRANOUS VSD OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10015577
• MDR Text Key: 189842995
• Report Number: 2135147-2020-00191
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CVD0099
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention