BEUDAMED
    FDA Adverse Event Death Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1060365 · Received June 11, 2008

    Report

    Report Number
    3003681312-2008-00062
    Event Type
    Death
    Date Received
    June 11, 2008
    Date of Event
    March 27, 2008
    Report Date
    May 21, 2008
    Manufacturer
    ST. JUDE MEDICAL, PUERTO RICO, B.V.
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFO RECEIVED, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTIONS 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 IFU STATES IF 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 FOUND TO BE NO LUMINAL NARROWING OF 40% OR GREATER WITHIN 5 MM OF THE PUNCTURE SITE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A DIAGNOSTIC AORTO-ILIAC-FEMORAL ANGIOGRAM WITH RUNOFF (AIF) PROCEDURE, A 6F ANGIO-SEAL VIP WAS DEPLOYED IN THE LEFT FEMORAL ARTERIOTOMY (LFA). WHILE IN RECOVERY, THE PT LOST DISTAL PULSES AND WAS TAKEN TO SURGERY. THE PT UNDERWENT AN AORTO-BIFEMORAL BYPASS GRAFT PLACEMENT. THE ANGIO-SEAL WAS REMOVED. THE PT DEVELOPED COMPLICATIONS FOLLOWING SURGERY AND 24 HOURS LATER, WENT BACK TO SURGERY FOR A COLON RESECTION, DEVELOPED COMPLICATIONS AND EXPIRED. THE PT WAS GIVEN HEPARIN, DOSE UNK, DURING BOTH SURGICAL PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ANGIO-SEAL VIP MGB ST. JUDE MEDICAL, PUERTO RICO, B.V. MA 2056290

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death| H| O| R