BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER MUSCULAR VSD OCCLUDER

    MDR report key: 3190482 · Received June 26, 2013

    Report

    Report Number
    2135147-2013-00057
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P040040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE 4MM MUSCVSD WAS RETURNED TO SJM AND DECONTAMINATED. THE OCCLUDER WAS GROSSLY AND MICROSCOPICALLY EXAMINED, AND NO ANOMALIES WERE FOUND. THE DEVICE MET DIMENSIONAL SPECIFICATIONS WHEN MEASURED WITH A CALIBRATED CALIPER. THE OCCLUDER WAS LOADED INTO A TEST LOADER, DEPLOYED AND RETRACTED WITHOUT DIFFICULTY OR DEFORMITY. 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, PRIOR TO SHIPMENT. THE CAUSE OF THE REPORTED EVENT REMAINS UNKNOWN.

    Description of Event or Problem · 1

    A 4MM AMPLATZER MUSCULAR VSD OCCLUDER (MUSCVSD) WAS ATTEMPTED BUT NOT RELEASED WHEN THE MUSCVSD WAS FOUND TO BE TOO LONG FOR THE TUNNEL-SHAPED DEFECT. AFTER THE MUSCVSD WAS REMOVED, A TRANS-ESOPHAGEAL ECHO (TEE) REVEALED A CLOT. THE PATIENT'S ACT WAS OVER 200 BUT DUE TO THE LONG TEE EVALUATION AND THE NATURE OF THE FENESTRATION, THE PHYSICIAN WAS NOT SURPRISED AT THE THIN THROMBUS FORMATION. ADDITIONAL HEPARIN WAS ADMINISTERED, A PORTION OF THE THROMBUS WAS ASPIRATED AND THE REMAINDER RESOLVED ON ITS OWN. NO ADVERSE PATIENT EFFECTS WERE REPORTED AND THE PATIENT WAS DISCHARGED THE FOLLOWING MORNING. THE PROCEDURE WILL BE RESCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291215 AMPLATZER MUSCULAR VSD OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-VSD-MUSC-004 1211018915

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention