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

Device Problem Biocompatibility (2886)

Patient Problems Cardiac Tamponade (2226); Cardiac Perforation (2513)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, 20 patients were implanted with an amplatzer cardiac plug and 24 were implanted with an amplatzer amulet.One patient had a tamponade due to the delivery system used.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 amplatzer cardiac plug and amulet that may be related to complications post procedure.Details are listed in the article, titled "dual antiplatelet therapy after percutaneous left atrial appendage occlusion: single center experience with the amplatzer cardiac plug" it was reported in the article that 44 patients were implanted with an amplatzer cardiac plug (20) or amulet (24) between february 2011 to october 2016.39 patient were included in the analysis.These patients had an average age of 78, with 20 of them being male.The baseline characteristics include: permanent atrial fibrillation, congestive heart failure, hypertension, diabetes, stroke/tia, vascular disease, and bleeding.A major adverse event observed was one case of tamponade due to left atrial appendage perforation by the delivery system that was treated successfully by pericardiocentesis after device deployment.

• 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: 9990479
• MDR Text Key: 188903230
• Report Number: 2135147-2020-00153
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• 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: 03/31/2020
• 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: 78 YR