BEUDAMED
    FDA Adverse Event Death Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 1221383 · Received November 4, 2008

    Report

    Report Number
    3003681312-2008-00110
    Event Type
    Death
    Date Received
    November 4, 2008
    Date of Event
    October 7, 2008
    Report Date
    November 4, 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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFO RECEIVED, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. A PAPER PRINT RADIOGRAPHIC IMAGE AND AN OPERATIVE REPORT WERE RECEIVED WITH THE COMPLAINT. THE RADIOGRAPHIC IMAGE REPRESENTS A CONTRAST ENHANCED VIEW OF BILATERAL FEMORAL ARTERIES. THE ANGIO-SEAL DEVICES INSTRUCTIONS FOR USE (IFU) CAUTIONS SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OF FRAGMENTS, OR SURGICAL INTERVENTION. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) STATES IF PTS HAVE CLINICALLY SIGNIFICANT PERIPHERAL VASCULAR DISEASE, BASED ON PUBLISHED MEDICAL LITERATURE, THE ANGIO-SEAL DEVICE CAN BE DEPLOYED SAFELY IN PT'S ARTERIES >5MM 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 FOLLOWING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), THE PT'S GROIN WAS SEALED WITH A 6F ANGIO-SEAL STS PLUS. A FEW DAYS LATER THE PT WAS RELEASED FROM HOSPITAL. FIFTY FOUR DAYS LATER, THE PT WAS ADMITTED TO THE HOSPITAL WITH A COLD RIGHT LEG. AN ANGIOGRAM REVEALED AN OCCLUDED RIGHT FEMORALIS COMMUNIS ARTERY. THE PT UNDERWENT SURGICAL INTERVENTION. EXTENSIVE ARTHEROSCLEROTIC PLAQUE MATERIAL WAS PRESENT IN THE ARTERIES LEADING TO AND FROM THE PROXIMAL OBSTRUCTION. THE ANGIO-SEAL WAS REMOVED. GANGRENE WAS PRESENT IN THE RIGHT LEG. THE SURGERY WAS PERFORMED UNDER GENERAL ANESTHESIA AND THE PT EXPIRED FOLLOWING SURGERY. THE PT HAD MEDICAL HISTORY OF 3 VESSEL CORONARY ARTERY DISEASE, ATHEROSCLEROSIS, PERIPHERAL VASCULAR DISEASE, AND GANGRENE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS 6F ANGIO-SEAL STS PLUS MGB ST. JUDE MEDICAL PUERTO RICO, B.V. NA 2076369

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death| H| R