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U.S. Department of Health and Human Services

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

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AGA MEDICAL CORPORATION AMPLATZER TORQVUE (UNKNOWN) CATHETER, PERCUTANEOUS Back to Search Results
Model Number CVD0111
Device Problem Biocompatibility (2886)
Patient Problems Stroke/CVA (1770); 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 through a research article titled, "long-term follow-up after left atrial appendage occlusion with comparison of transesophageal echocardiography versus computed tomography to guidemedical therapy and data about postclosure cardioversion¿ that 135 patients were implanted with a left atrial appendage (laa) occluder 2009 to 2015. The implanted devices were 73 watchman, 59 amplatzer cardiac plug, and 3 amplatzer amulet. Ninety one (91) of the patients had a concomitant procedure of pulmonary vein isolation (pvi). Two deaths related to the procedure or device were reported. One patient (after a concomitant procedure) died following a hemorrhagic stroke and the other patient died after a subacute tamponade. It was not reported which devices were associated to these deaths. Additional information could not be obtained.

 
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Brand NameAMPLATZER TORQVUE (UNKNOWN)
Type of DeviceCATHETER, 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 Key10024235
MDR Text Key189842010
Report Number2135147-2020-00167
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeSZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/20/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/05/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCVD0111
Device Catalogue NumberCVD0111
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 Received07/15/2020
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: 05/05/2020 Patient Sequence Number: 1
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