BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 1142755 · Received August 12, 2008

    Report

    Report Number
    2182269-2008-00188
    Event Type
    Injury
    Date Received
    August 12, 2008
    Report Date
    August 12, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) CAUTION, 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 FOLLOWING AN AORTA-ILIAC PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), AN 8F ANGIO-SEAL STS PLUS WAS DEPLOYED. SIX HOURS LATER, THE PATIENT COMPLAINED FOR RIGHT LEG PAIN BELOW THE LEVEL OF THE KNEE. A DOPPLER ULTRASOUND REVEALED AN OCCLUSION AT THE LEVEL OF THE TRIFURCATION OF THE POPLITEAL ARTERY. THE PATIENT UNDERWENT SURGICAL INTERVENTION WITH SUCCESSFUL REMOVAL OF THE OCCLUSION. IT IS NOT KNOWN IF THE ANCHOR WAS IN THE REMOVED OCCLUSION. THE PATIENT WAS REPORTED TO BE WELL AND DOING BETTER AFTER THE PROCEDURE. THE IMPLANT, EXPLANT, AND EVENT DATES ARE UNKNOWN.

    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