MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER MUSCULAR VSD OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number 9-VSD-MUSC-010

Device Problem Human-Device Interface Problem (2949)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

The article, "transcatheter closure of residual and iatrogenic ventricular septal defects: tertiary center experience and outcome" was reviewed.This research article presents a case on a (b)(6) female patient who underwent previous transcatheter closure of a ventricular septal defect (vsd) with 10mm amplatzer muscular vsd occluder at the age of 14.3 years later, a residual peri-membranous vsd proximal to the previous device measuring 4 mm was visualized on transthoracic echocardiogram (tte) and by left ventriculography.The patient underwent another transcatheter procedure to close the residual vsd.A 4mm amplatzer duct occluder ii was successfully implanted with no residual shunt shown on angiogram and tte.No additional information was provided.The article concluded that transcatheter closure of post-operative and post-intervention residual/iatrogenic vsds represents a safe, feasible, and effective therapeutic approach.The primary and correspondence author of the article is (b)(6).

Manufacturer Narrative

As reported in a research article, three years after amplatzer vsd occluder implant, a patient has a residual peri-membranous vsd proximal to the device and an amplatzer duct occluder ii was implanted off-label.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.

• Brand Name: AMPLATZER MUSCULAR VSD OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 12658178
• MDR Text Key: 281920812
• Report Number: 2135147-2021-00415
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• PMA/PMN Number: P040040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-VSD-MUSC-010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR