BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER® MUSCULAR VSD OCCLUDER

    MDR report key: 1915273 · Received December 6, 2010

    Report

    Report Number
    2135147-2010-00177
    Event Type
    Injury
    Date Received
    December 6, 2010
    Date of Event
    November 10, 2010
    Report Date
    January 10, 2011
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P040040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONTRARY TO THE INITIAL MDR SUBMISSION, THE DEVICE WILL NOT BE RETURNED AS EXPECTED SO ANALYSIS CANNOT BE PERFORMED. ALSO, WE WERE ADVISED THAT THE PHYSICIAN DID NOT ASSERT ANY ALLEGATION AGAINST THE AMPLATZER MUSCULAR VSD OCCLUDER AND THAT THE PERFORATION WAS CAUSED BY OPERATOR ERROR. IF FURTHER INFORMATION BECOMES AVAILABLE, AN UPDATED REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT BEEN RETURNED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS PAIN AND PSEUDOTUMOR.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL INFORMATION RECEIVED, THE 10MM AMPLATZER MUSCULAR VSD OCCLUDER (MUSCVSD) PERFORATED THE PATIENT'S LEFT VENTRICULAR (LV) WALL. THE MUSCVSD WAS REMOVED AND THE PERFORATION WAS SURGICALLY REPAIRED. THE PATIENT IS STABLE AND IS SCHEDULED TO HAVE THE DEFECT CLOSED PERCUTANEOUSLY - TRANSCATHETER - IN THE NEAR FUTURE. THE DEVICE IS EXPECTED TO BE RETURNED; WHEN ANALYSIS IS COMPLETE, AN UPDATED REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER® MUSCULAR VSD OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-VSD-MUSC-010 0911166937

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention