BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER VASCULAR PLUG

    MDR report key: 5367118 · Received January 14, 2016

    Report

    Report Number
    2135147-2016-00006
    Event Type
    Injury
    Date Received
    January 14, 2016
    Report Date
    December 15, 2015
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    KRD
    PMA / PMN Number
    K031810
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    GTIN NUMBER: UNKNOWN SINCE THE BATCH/LOT NUMBER WAS NOT PROVIDED. (B)(4). THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE SERIAL NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION COMES FROM "THE (B)(6): A CASE OF LATE OCCLUSION OF THE LEFT SUBCLAVIAN ARTERY(LT-SCA) AFTER THE DEPLOYMENT OF 14 MM AMPLATZER VASCULAR PLUG (AVP) T IN A (B)(6) MALE PATIENT TREATED WITH THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR). AT THE FIRST SURGICAL INTERVENTION, AN ASCENDING AORTIC REPLACEMENT WAS PERFORMED FOR THE TREATMENT OF AN AORTIC ANEURYSM LOCATED BETWEEN AN AORTIC ARCH AND A DESCENDING AORTA. AS THE SYNTHETIC GRAFT WAS ANASTOMOSED WITH THE TERMINATION OF THE LEFT AXILLARY ARTERY BY USING THE SEPARATED GRAFT TECHNIQUE, THE LT-SCA REMAINED PATENT AND THERE WAS PERSISTENT BLOOD FLOW IN THE LT-SCA. AT THE SECOND SURGICAL INTERVENTION, A 14 MM AVP (LOT UNKNOWN) WAS DEPLOYED TO EMBOLIZE THE ROOT OF LT-SCA AND A STENT GRAFT WAS DEPLOYED FROM THE SYNTHETIC GRAFT TO REPAIR THE ASCENDING AORTA TO THE DESCENDING AORTA. POSTOPERATIVELY, THE PATIENT DEVELOPED ANEMIA AND JAUNDICE. AN ANGIOGRAPHY WAS PERFORMED SEVEN DAYS AFTER THE PROCEDURE AND BLOOD FLOW WAS OBSERVED AROUND THE DEPLOYED AVP IN THE LT-SCA AND A TYPE II ENDOLEAK FROM THE LT-SCA WAS CONFIRMED AS WELL. THE PHYSICIAN CONSIDERED THE PRESENCE OF HEMOLYTIC ANEMIA CAUSED BY THE RESIDUAL BLOOD FLOW PASSING THROUGH THE AVP. AT THE SAME TIME, THROMBOCYTOPENIA AND PROLONGED BLOOD CLOTTING WERE CONFIRMED. A BLOOD TRANSFUSION WITH RED BLOOD CELLS (RBC), PLATELETS (PLT) AND FRESH FROZEN PLASMA (FFP) WAS PERFORMED, AND THEN THE DEPLOYMENT SITE OF THE AVP IN THE LT-SCA BECAME COMPLETELY OBSTRUCTED SPONTANEOUSLY. SUBSEQUENTLY, THE ANEMIA AND JAUNDICE SUBSIDED. THE AVP REMAINS IMPLANTED. THE PHYSICIAN STATED THAT THE AVP WAS EASILY DEPLOYED IN THE VESSEL BRANCH BUT IT IS PROBABLE THAT IN THE PRESENCE OF ANEMIA AND PROLONGED CLOTTING TIME THE VESSELS WOULD NOT BE EMBOLIZED COMPLETELY AND HIS RECOMMENDATION IS TO PAY CAREFUL ATTENTION TO DEPLOY THE AVP IN THIS TYPE OF PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24406 AMPLATZER VASCULAR PLUG ARTERIAL EMBOLIZATION DEVICE KRD AGA MEDICAL CORPORATION 9-PLUG-014

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R