BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER VASCULAR PLUG II

    MDR report key: 3092034 · Received May 3, 2013

    Report

    Report Number
    2135147-2013-00042
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 9, 2013
    Report Date
    May 2, 2013
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    KRD
    PMA / PMN Number
    K071699
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AMPLATZER VASCULAR PLUG II WAS RECEIVED AT SJM AND WAS DECONTAMINATED. THE PLUG WAS GROSSLY AND MICROSCOPICALLY EXAMINED, AND NO ANOMALIES WERE FOUND. IT MET DIMENSIONAL SPECIFICATIONS WHEN MEASURED WITH A CALIBRATED CALIPER. THE DEVICE WAS LOADED INTO A TEST 6F LOADER, DEPLOYED AND RETRACTED WITHOUT DIFFICULTY OR DEFORMATION. DURING MANUFACTURING, THIS DEVICE UNDERWENT A SERIES OF INSPECTIONS AND TESTS TO CONFIRM PROPER FUNCTION, INCLUDING A TEST SIMULATING LOADING AND DEPLOYMENT. A REVIEW OF MANUFACTURING DOCUMENTATION CONFIRMED THIS DEVICE SUCCESSFULLY COMPLETED THESE TESTS. THE CAUSE OF THE REPORTED EVENT REMAINS UNKNOWN.

    Description of Event or Problem · 1

    A 14MM AMPLATZER VASCULAR PLUG II (AVPII) WAS SELECTED TO OCCLUDE AN AORTIC PARA-VALVULAR LEAK. SHORTLY AFTER THE AVPII WAS DEPLOYED THE PATIENT'S BLOOD PRESSURE DROPPED. ECHO EVALUATION OF THE PATIENT'S CARDIAC FUNCTION SHOWED DECREASED LEFT VENTRICULAR FUNCTION WITH SEGMENTAL WALL MOTION ABNORMALITIES. THE AVPII WAS REMOVED AND CORONARY INTERVENTION WAS INITIATED. A THROMBUS WAS ALSO DISCOVERED DURING THE INTERVENTION IN THE CORONARY ARTERIES. ACCORDING TO THE PHYSICIAN, THE THROMBUS HAD A "RUBBERY FEEL" WHICH IS INDICATIVE OF A PRE-EXISTING CONDITION AND MAY HAVE BEEN RELATED TO AN AORTIC VALVE PROCEDURE TWO MONTHS PRIOR; HOWEVER, THE EXACT CAUSE OF THE THROMBUS WAS UNKNOWN. THE PATIENT WAS REPORTED TO BE ADEQUATELY HEPARINIZED DURING THE AVPII PROCEDURE. THE THROMBUS WAS ASPIRATED FROM THE CORONARY ARTERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194784 AMPLATZER VASCULAR PLUG II ARTERIAL EMBOLIZATION DEVICE KRD AGA MEDICAL CORPORATION 9-AVP2-014 1208099458

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention