BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERGARD KNITTED VASCULAR PROSTHESIS

    MDR report key: 259927 · Received January 21, 2000

    Report

    Report Number
    1640201-2000-00002
    Event Type
    Injury
    Date Received
    January 21, 2000
    Date of Event
    November 25, 1999
    Report Date
    December 20, 1999
    Manufacturer
    INTERVASCULAR, INC.
    Product Code
    DSY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH A PROSTHESIS IN AORTO BIFEMORAL POSITION IN 1996. DURING A ROUTINE MEDICAL VISIT ON 09/09/1999, EXAMINATION EVIDENCED EDEMA AT SCARPA. AN ECHO DOPPLER WAS THEN PERFORMED: GRAFT WAS PATENT AND A SEROMA OR FALSE ANEURYSMS WERE SUSPECTED. A RE-INTERVENTION WAS PERFORMED IN 1999. VASCULAR SURGEON CONFIRMED THE SEROMA AND THE LEFT BRANCH OF THE GRAFT WAS EXPLANTED AND REPLACED BY A PTFE GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERGARD KNITTED VASCULAR PROSTHESIS COLLAGEN COATED VASCULAR PROSTHESIS DSY INTERVASCULAR, INC. IGK1407 95M08

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other