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); Pseudoaneurysm (2605); Pericardial Effusion (3271)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a study, titled "left atrial appendage closure in patients with a reduced left ventricular ejection fraction: results from the multicenter german laarge registry" was conducted with different standard commercial devices in a prospective, non-randomized registry depicting the clinical reality of laac in germany involving 619 patients from 37 centers between july 2014 and january 2016.The devices used included 276 watchman devices, 170 amplatzer cardiac plugs, 154 amplatzer amulets and 19 people received other devices.Procedural complications reported includes stroke in 4 patients, severe bleeding in 12 patients, pseudoaneurysm in 6, pericardial effusion requiring surgery in 3, access site infection in 1 patient.It was not specified what devices were associated with these complications.Additional information could not be obtained.

Manufacturer Narrative

Additional information: h6, h10.An event of cardiac perforation was reported.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.

• Brand Name: AMPLATZER® TORQVUE® (UNKNOWN)
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10024224
• MDR Text Key: 189980062
• Report Number: 2135147-2020-00195
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention