BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER TORQVUE DELIVERY SYSTEM

    MDR report key: 2831073 · Received November 14, 2012

    Report

    Report Number
    2135147-2012-00170
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 29, 2012
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    DQY
    PMA / PMN Number
    K072313
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION TO MANUFACTURE DATE, 08/03/2012.THE AMPLATZER TORQVUE DELIVERY SYSTEM ASSOCIATED WITH THIS COMPLAINT WAS NOT RETURNED TO SJM FOR ANALYSIS. DURING MANUFACTURING, THIS DELIVERY SYSTEM LOT UNDERWENT A SERIES OF INSPECTIONS AND TESTS TO CONFIRM PROPER FUNCTION. A REVIEW OF MANUFACTURING DOCUMENTATION CONFIRMED THIS DELIVERY SYSTEM LOT SUCCESSFULLY COMPLETED THESE TESTS. THIS EVENT WAS REVIEWED BY THE ST. JUDE MEDICAL EROSION BOARD AND CONFIRMED THAT NO EROSION OCCURRED.

    Additional Manufacturer Narrative · 1

    (B)(4): DISCARDED BY CUSTOMER AT HOSPITAL.

    Description of Event or Problem · 1

    A 24MM AMPLATZER SEPTAL OCCLUDER WAS ATTEMPTED TO BE DEPLOYED INTO THE LEFT UPPER PULMONARY VEIN (LUPV) BUT THE DEVICE DEPLOYED INTO THE LEFT ATRIAL APPENDAGE (LAA). THE ASO WAS RETRACTED BACK INTO THE AMPLATZER TORQVUE 45 DELIVERY SHEATH (DTV45) AND RE-DEPLOYED INTO THE LEFT ATRIUM. THE ASO SLIPPED INTO THE LEFT ATRIUM AFTER THE WIGGLE TEST WAS PERFORMED. ANOTHER DEPLOYMENT WAS GOING TO BE ATTEMPTED, BUT A PERICARDIAL EFFUSION WAS OBSERVED AND THE PATIENT'S BLOOD PRESSURE DROPPED, WHICH DEVELOPED INTO CARDIAC TAMPONADE. THE PERICARDIAL EFFUSION WAS DRAINED AND THE PATIENT'S BLOOD PRESSURE RECOVERED. THE PATIENT'S CONDITION DETERIORATED WHEN THE NORADRENALIN (DOSAGE UNKNOWN) STARTED TO LOSE EFFECT AND THE PATIENT'S BLOOD PRESSURE DROPPED AGAIN. THE PATIENT WAS REFERRED FOR SURGERY, WHERE A PERFORATION OF THE LUPV WAS OBSERVED AND THE DEFECT WAS CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER TORQVUE DELIVERY SYSTEM DELIVERY SYSTEM DQY AGA MEDICAL CORPORATION 9-ITV10F45/80 1208038689

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R