BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 4820311 · Received June 5, 2015

    Report

    Report Number
    2135147-2015-00061
    Event Type
    Injury
    Date Received
    June 5, 2015
    Date of Event
    December 2, 2014
    Report Date
    May 15, 2015
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RESULTS OF THIS INVESTIGATION ARE INCONCLUSIVE BECAUSE THE ASO WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE OCCLUDER MET ALL VISUAL, DIMENSIONAL, AND FUNCTIONAL SPECIFICATIONS AT THE TIME IT WAS MANUFACTURED, PRIOR TO SHIPMENT. THERE WAS NO EVIDENCE TO SUGGEST THERE WAS AN INTRINSIC DEFECT IN THE OCCLUDER, AND THE CAUSE FOR THE REPORTED EVENT REMAINS UNKNOWN.

    Description of Event or Problem · 1

    AFTER A 30MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS DEPLOYED, THE PATIENT WENT INTO VENTRICULAR TACHYCARDIA AND REQUIRED A SINGLE DEFIBRILLATION TO RETURN TO NORMAL SINUS RHYTHM. FLUOROSCOPY CONFIRMED THE ASO HAD EMBOLIZED SUPERIOR TO THE PULMONIC VALVE. MULTIPLE ATTEMPTS WERE REQUIRED BEFORE THE ASO WAS FINALLY SNARED. THE PERCUTANEOUS REMOVAL OF THE ASO RESULTED IN A LARGER ATRIAL SEPTAL DEFECT AND THE ONSET OF SEVERE TRICUSPID REGURGITATION. SURGICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364883 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-030 4797078

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention