BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENAFLO EPTFE VASCULAR GRAFT

    MDR report key: 529854 · Received June 14, 2004

    Report

    Report Number
    2020394-2004-00057
    Event Type
    Injury
    Date Received
    June 14, 2004
    Date of Event
    April 14, 2004
    Report Date
    May 18, 2004
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    FIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUBSEQUENT TO A FAILED CIMINO FISTULA IN THE ELBOW, A VENAFLO GRAFT WAS IMPLANTED IN THE LEFT LOWER ARM BETWEEN THE ANTECUBITAL ARTERY AND BASILIC VEIN. ONE YEAR AFTER IMPLANTATION, DUPLEX SONOGRAPHY SHOWED "MASSIVE CALCIFICATION" OF THE GRAFT. THEREFORE, PTA COULD NOT BE PERFORMED. A SURGICAL REVISION WAS PERFORMED, A 5CM SEGMENT OF "BRITTLE" GRAFT REMOVED, AND AN INTERPOSITION GRAFT WAS IMPLANTED. THE GRAFT OCCLUDED AGAIN. NINE DAYS LATER THE REMAINING "HARDENED" GRAFT WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENAFLO EPTFE VASCULAR GRAFT EPTFE CUFFED AV ACCESS GRAFT FIQ BARD PERIPHERAL VASCULAR, INC. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention