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

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Idioventricular Rhythm (1923); Complete Heart Block (2627)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, 18 patients were implanted with amplatzer occluders for perimembranous ventricular septal defects.Complications of arrhythmia, valvular regurgitation, unstable device position, and residual shunt was reported.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.Please note, per the instructions for use for the ado ii, artmt100092303 revision a "indications and usage: the amplatzer¿ duct occluder ii is a percutaneous transcatheter occlusion device intended for the non-surgical closure of patent ductus arteriosus.".

Event Description

The article "re-evaluation of the criteria for asymmetric amplatzer occluders in the closure of perimembranous ventricular septal defects - a case series report" was reviewed.This research article is a retrospective single center experience to evaluate the criteria for the application of assymetrical amplatzer occluders for perimembranous ventricular septal defect (vsd) closures.Amplatzer occluder were associated to the study.There is no allegation of malfunction of the abbott device.The article concluded that a vsd patient should meet the following criteria to receive an asymmetric amplatzer occluder device: have a perimembranous vsd that meets the criteria for transcatheter closure of vsd; have a medium defect size <6mm; only experiencing mild or no aortic valvar regurgitation; and the presence of aneurysm does not influence the success rate of implantation.The primary author of the article is gang li, md , md of department of pediatrics, west china second university hospital, sichuan university, chengdu, sichuan.

• 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: 10775982
• MDR Text Key: 214365166
• Report Number: 2135147-2020-00462
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• 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
• Date Manufacturer Received: 10/23/2020
• 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