BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 1080482 · Received July 21, 2008

    Report

    Report Number
    2182269-2008-00179
    Event Type
    Injury
    Date Received
    July 21, 2008
    Date of Event
    September 1, 2007
    Report Date
    July 14, 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 FOR EVALUATION AND REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION 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, OR SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) FOR TREATMENT OF STENOSIS IN THE RIGHT COMMON ILIAC ARTERY, AN ANGIO-SEAL STS PLUS WAS DEPLOYED. AN 8F TERUMO LONG SHEATH WAS ALSO USED. THE PATIENT'S ANKLE BRACHIAL INDEX (ABI) DROPPED AND THE COLOR OF THE PATIENT'S LEG DID NOT IMPROVE. A CT SCAN AND ECHO CONFIRMED SEVERE STENOSIS AT THE PUNCTURE SITE. A WEEK LATER, A BALLOON ANGIOPLASTY (POBA) BY A LEFT CROSSOVER APPROACH WAS PERFORMED AND 20% OF THE STENOSIS STILL REMAINED. AN INTRAVASCULAR ULTRASOUND (IVUS) REVEALED AN ANCHOR-LIKE SUBSTANCE. THE PATIENT HAS RECOVERED WITH NO REPORTED CONSEQUENCES.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention