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 Hemorrhage/Bleeding (1888); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, out of 351 patients followed, 6 were implanted with amplatzer cardiac plugs.Complications included stroke, major bleeding, cardiac tamponade, severe vascular complications, and pericardial effusion.It is unknown if the complications were experienced by patients who were implanted with the amplatzer cardiac plug.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 in the article titled, "efficacy and safety of left atrial appendage closure in non-valvular atrial fibrillation in patients over 75 years" that 351 patients were implanted with 341 watchman devices and 6 amplatzer cardiac plug.Complications post procedure included stroke, major bleeding, cardiac tamponade, severe vascular complication, and pericardial effusion.It was not specified what products resulted to these complications.Additional information could not be obtained.

• 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: 9980784
• MDR Text Key: 188350777
• Report Number: 2135147-2020-00169
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• 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
• Date Manufacturer Received: 03/23/2020
• 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): Hospitalization; Life Threatening; Other; Required Intervention