BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER MUSCULAR VSD OCCLUDER

    MDR report key: 3900450 · Received June 27, 2014

    Report

    Report Number
    2135147-2014-00061
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P040040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE 10MM MUSCVSD WAS RETURNED TO SJM AND DECONTAMINATED. THE OCCLUDER WAS GROSSLY AND MICROSCOPICALLY EXAMINED, AND NO ANOMALIES WERE FOUND. THE MUSCVSD MET DIMENSIONAL SPECIFICATIONS WHEN MEASURED WITH A CALIPER. THE OCCLUDER WAS LOADED INTO A TEST LOADER, DEPLOYED AND RETRACTED WITHOUT DIFFICULTY OR DEFORMATION, UNDER NON-PHYSIOLOGICAL CONDITIONS. THE DEVICE HISTORY RECORD FOR THIS PRODUCT WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE REVIEW DETERMINED THE PROCESS WAS PERFORMED AND COMPLETED IN ACCORDANCE WITH SJM SPECIFICATIONS AND PROCEDURES. THE RESULTS OF THIS INVESTIGATION CONFIRMED THE MUSCVSD MET ALL FUNCTIONAL AND DIMENSIONAL SPECIFICATIONS WHEN ANALYZED AT SJM. THERE WAS NO EVIDENCE TO SUGGEST THERE WAS AN INTRINSIC DEFECT IN THE OCCLUDER, AND THE CAUSE OF THE EMBOLIZATION REMAINS UNKNOWN.

    Description of Event or Problem · 1

    DUE TO THE PATIENT'S LARGE PATENT DUCTUS ARTERIOSUS (PDA), A 10MM AMPLATZER MUSCULAR VSD OCCLUDER (MUSCVSD) WAS IMPLANTED. AFTER THE MUSCVSD WAS DEPLOYED, A WIGGLE TEST AND FLUOROSCOPY CONFIRMED SATISFACTORY DEVICE PLACEMENT, SO THE DEVICE WAS RELEASED. THE PATIENT WAS HEMODYNAMICALLY STABLE AND THE PATIENT WAS RELEASED TO THE POST-ANESTHESIA RECOVERY UNIT. APPROXIMATELY TWO HOURS LATER, THE PATIENT'S DIASTOLIC PRESSURE DROPPED 30 POINTS AND AN X-RAY DETERMINED THE MUSCVSD DEVICE HAD EMBOLIZED TO THE RIGHT PULMONARY ARTERY. PERCUTANEOUS RETRIEVAL WAS UNSUCCESSFUL DESPITE ATTEMPTS FOR THREE HOURS USING VARIOUS RETRIEVAL DEVICES. THE PATIENT WAS REFERRED FOR SURGERY WHERE THE MUSCVSD WAS EXPLANTED THE SAME DAY AND PDA WAS SURGICALLY REPAIRED. THE PATIENT WAS REPORTEDLY STABLE THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377686 AMPLATZER MUSCULAR VSD OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-VSD-MUSC-010 4506206

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention