BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS

    MDR report key: 428314 · Received November 19, 2002

    Report

    Report Number
    2182269-2002-00115
    Event Type
    Injury
    Date Received
    November 19, 2002
    Date of Event
    October 18, 2002
    Report Date
    November 19, 2002
    Manufacturer
    ST.JUDE MEDICAL, DAIG DIVISION, INC.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A 6F ANGIO-SEAL DEVICE WAS DEPLOYED WITH SLIGHT OOZING NOTED AT THE PUNCTURE SITE POST-DEPLOYMENT. LIGHT MANUAL PRESSURE WAS HELD FOR TWO MINUTES AND HEMOSTASIS WAS OBTAINED WITH NO OTHER COMPLICATIONS. A PREPLACEMENT FEMORAL ANGIOGRAM REVEALED 30 PERCENT STENOSIS JUST BELOW THE SHEATH INSERTION SITE. ALTHOUGH THE PATIENT HAD A HISTORY OF PERIPHERAL VASCULAR DISEASE, THE USER CONSIDERED THIS PATIENT IS A GOOD CANDIDATE TO RECEIVE THE DEVICE. ONE DAY POST-PROCEDURE THE PATIENT COMPLAINT OF LIGHT LEG PAIN. THREE DAYS POST-PROCEDURE, THE PATIENT WAS TAKEN FOR AN ANGIOGRAM WHICH REVEALED A DISSECTION AND THROMBOSIS AT THE DEPLOYMENT SITE. THE PATIENT WAS THEN TAKEN TO OR TO SURGICALLY REMOVE THE DEVICE. THE SURGEON FOUND RUPTURED PLAQUE IN THE ARTERY AT THE INSERTION SITE OF THE DEVICE; LIKELY CAUSED BY THE DEVICE ANCHOR LIFTING PLAQUE AND CAUSING DIMINSHED BLOOD FLOW DOWN THE ARTERY. THE PATIENT IS REPORTED TO BE DOING WELL AND RECOVERING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention