BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 2231199 · Received August 25, 2011

    Report

    Report Number
    2182269-2011-00135
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 25, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE FOR THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) CAUTIONS, SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) STATES IF THE PT'S HAVE CLINICALLY SIGNIFICANT PERIPHERAL VASCULAR DISEASE, BASED ON PUBLISHED MEDICAL LITERATURE, THE ANGIO-SEAL DEVICE CAN BE DEPLOYED SAFELY IN PT ARTERIES >5 MM DIAMETER WHEN THERE IS FOND TO BE NO LUMINAL NARROWING OF 40% OR GREATER WITHIN 5 MM OF THE PUNCTURE SITE. ACCORDING TO THE IFU, THE SAFETY AND EFFECTIVENESS OF THE ANGIO-SEAL HAS NOT BEEN ESTABLISHED IN PTS WITH CLINICALLY SIGNIFICANT PERIPHERAL VASCULAR DISEASE.

    Description of Event or Problem · 1

    A 6F ANGIO-SEAL VIP WAS SELECTED FOR CLOSURE OF THE COMMON FEMORAL ARTERY. FOLLOWING THE DEPLOYMENT, AN ULTRASOUND WAS PERFORMED. THE ULTRASOUND REVEALED THAT THE PT HAD A COMPLETE VESSEL OCCLUSION IN THE COMMON FEMORAL ARTERY AND THAT THE ARTERY WAS DISEASED. THE PT REQUIRED SURGICAL INTERVENTION TO RESTORE THE BLOOD FLOW TO THE LOWER EXTREMITY. SHE WAS REPORTEDLY STABLE FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP MGB ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R THE PT WAS TAKING ANTI-COAGULANTS AS PRESCRIBED.