BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 3010583 · Received March 19, 2013

    Report

    Report Number
    2135147-2013-00025
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 28, 2013
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASO WAS RECEIVED IN THE LAB AND WAS DECONTAMINATED. IT WAS GROSSLY AND MICROSCOPICALLY EXAMINED AND NO ANOMALIES WERE FOUND. THE ASO MET DIMENSIONAL SPECIFICATIONS WHEN MEASURED WITH A CALIBRATED CALIPER. 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 PATIENT IMPLANTED WITH A 16MM AMPLATZER SEPTAL OCCLUDER (ASO) LOST HER P WAVE DURING THE PROCEDURE SO THE ASO, STILL ATTACHED TO THE DELIVERY CABLE, WAS REMOVED TO ENSURE THE ANOMALY WAS NOT DEVICE-RELATED. ANOTHER 16MM ASO WAS ATTEMPTED WITH THE SAME RESULT AND WAS REMOVED WHILE STILL ATTACHED TO THE DELIVERY CABLE. THE PATIENT WAS GIVEN ATROPINE TO RESTORE NORMAL RHYTHM AND THE PROCEDURE WAS ABORTED. THE PATIENT WAS REFERRED FOR SURGICAL CLOSURE OF THE DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114196 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-016 1210045208

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention