MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER® TORQVUE® (UNKNOWN) CATHETER, PERCUTANEOUS

Model Number CVD0111

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Cardiac Tamponade (2226)

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported in a research article that a study was conducted from february 2016 to january 2019 where 527 patients were implanted with an amplatzer septal occluder and some experienced complications post-procedure. One patient underwent surgical drainage due to a large pericardial effusion that led to a tamponade after suffering a tear in the left upper pulmonary vein and left atrial junction. The patient expired the next day after the surgery. Manufacturer report numbers: 2135147-2020-00082; 2135147-2020-00083.

• Brand Name: AMPLATZER® TORQVUE® (UNKNOWN)
• Type of Device: CATHETER, PERCUTANEOUS
• 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: 9781558
• MDR Text Key: 181820917
• Report Number: 2135147-2020-00088
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (Y/N): N
• Reporter Country Code: NP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: FOREIGN,HEALTH PROFESSIONAL,L

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/05/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 03/03/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: CVD0111
• Device Catalogue Number: CVD0111
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 03/13/2020
• 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 TREATMENT DATA

Date Received: 03/03/2020 Patient Sequence Number: 1