BEUDAMED
    FDA Adverse Event Death Summary report: N

    8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 1150446 · Received September 4, 2008

    Report

    Report Number
    2182269-2008-00197
    Event Type
    Death
    Date Received
    September 4, 2008
    Date of Event
    August 16, 2008
    Report Date
    September 4, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED; THEREFORE, AN EVALUATION COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFO PROVIDED TO ST. JUDE MEDICAL, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL INSTRUCTION FOR USE (IFU) STATES SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OF SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) FOR A PROXIMAL STENOSIS, A STENT WAS PLACED BELOW THE COMMON FEMORAL ARTERY (CFA) PUNCTURE SITE. AN ANGIO-SEAL WAS SELECTED FOR USE. A PRE-DEPLOYMENT ANGIOGRAM REVEALED MILD CALCIFICATION AT THE PUNCTURE SITE AND THE VESSEL LUMEN DIAMETER WAS 4-5 MM. A 7F COOK SHEATH WAS ALSO USED. A 0.035 TERUMO RADIFOCUS 220 CM GUIDEWIRE WAS USED TO INSERT THE LOCATOR/SHEATH ASSEMBLY INTO THE PUNCTURE SITE INSTEAD OF THE PROVIDED GUIDEWIRE. DURING ANGIO-SEAL DEPLOYMENT, AFTER THE BLOOD FLOW WAS CONFIRMED, THE PROCEDURE WAS PERFORMED BY ANOTHER PHYSICIAN. THE ANGIO-SEAL WAS DEPLOYED ANTEGRADE AND HEMOSTASIS WAS ACHIEVED. THE PT RETURNED TO THE HOSP ROOM AND AMBULATED 4-6 HRS LATER. ONE DAY LATER, AN ULTRASOUND AND INTRAVASCULAR ULTRASOUND (IVUS) REVEALED A THROMBOTIC OCCLUSION FROM BELOW THE CFA TO THE INSIDE OF THE STENT. A NARROW GAP WAS SEEN BY IVUS BETWEEN THE ARTERY WALL AND THE ANCHOR. ANOTHER PTA WAS PERFORMED USING A 7 MM DIAMETER BALLOON AND THROMBUS WAS ASPIRATED. THE NARROW GAP BETWEEN THE ARTERY WALL AND THE ANCHOR REMAINED. THE PT LATER DETERIORATED AND EXPIRED DUE TO RESPIRATORY FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS 8F ANGIO-SEAL STS PLUS MGB ST. JUDE MEDICAL NA 2056072

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death| R