BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER® TORQVUE® (UNKNOWN)

    MDR report key: 9990479 · Received April 23, 2020

    Report

    Report Number
    2135147-2020-00153
    Event Type
    Injury
    Date Received
    April 23, 2020
    Report Date
    April 23, 2020
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454010 AMPLATZER® TORQVUE® (UNKNOWN) CATHETER, PERCUTANEOUS DQY AGA MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention