BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 3032534 · Received April 3, 2013

    Report

    Report Number
    2135147-2013-00033
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ST. JUDE MEDICAL COULD NOT EVALUATE THE ASO INVOLVED IN THIS INCIDENT SINCE IT WAS NOT RETURNED TO US. THE DEVICE'S MANUFACTURING RECORDS COULD NOT BE REVIEWED SINCE THE LOT NUMBER FOR THE AFFECTED PRODUCT WAS NOT PROVIDED TO ST. JUDE MEDICAL. HOWEVER, EACH DEVICE IS INSPECTED BY CERTIFIED OPERATORS TO ENSURE EACH DEVICE IS ACCEPTABLE DURING MANUFACTURING AND PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    A PATIENT WAS IMPLANTED WITH A 16MM AMPLATZER SEPTAL OCCLUDER (ASO) ON (B)(6) 2010 AND HAS NOW RETURNED WITH SHORTNESS OF BREATH. AN ECHOCARDIOGRAM WAS PERFORMED AND THE ASO WAS NOT FOUND IN THE HEART. A FULL BODY CT WAS PERFORMED AND THE ASO WAS FOUND IN THE THORACIC AORTA. THE PATIENT RETURNED TO THE CATH LAB WHERE THE ASO WAS SNARED WITH A 10MM EV3 SNARE IN THE THORACIC AORTA. THE ASO WAS ATTEMPTED TO BE RECAPTURED THROUGH A 80CM, 13F SHEATH, BUT THE ASO WOULD NOT COLLAPSE INTO THE SHEATH. NO AMOUNT OF PRESSURE COULD GET THE ASO TO FOLD INTO THE SHEATH. THE ASO WAS MOVED WITH THE SNARE TO THE RIGHT ILIAC ARTERY, AND THE PATIENT WAS TRANSFERRED TO SURGICAL THEATRES FOR SURGICAL BYPASS OF THE ASO IN THE ILIAC BY GRAFT ON THE (B)(6) 2013. THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135575 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-016 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization