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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 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.
 
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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 Key10024224
MDR Text Key189980062
Report Number2135147-2020-00195
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeGM
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 05/19/2020
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
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 Received05/08/2020
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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