BEUDAMED
    FDA Adverse Event Other Summary report: N

    GELSOFT

    MDR report key: 527956 · Received May 28, 2004

    Report

    Report Number
    9612515-2004-00004
    Event Type
    Other
    Date Received
    May 28, 2004
    Date of Event
    April 20, 2004
    Report Date
    May 12, 2004
    Manufacturer
    VASCUTEK LTD.
    Product Code
    DSY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE INCIDENT IS BEING REPORTED AS A RESULT OF INTERVENTION BEING REQUIRED TO REPLACE A GRAFT. THE PT HAD BEEN IMPLANTED WITH A VASCUTEX GELSOFT BIFURCATED GRAFT IN 09/1992. THE PT PRESENTED WITH A PAIN IN PT'S LEFT LEG. AN ANGIOGRAM WAS PERFORMED AND A LARGE PSEUD0-ANEURYSM WAS IDENTIFIED. THE GRAFT WAS EXPLANTED AND REPLACED WITH A NEW BIFURCATED GRAFT. DR INDICATED HE SAW A LARGE HOLE ON THE LEFT HAND SIDE OF THE GRAFT. THE INCIDENT CONCERNS THE REMOVAL OF A VASCULAR PROSTHESIS DUE TO THE PRESENCE OF A PSEUDO ANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GELSOFT VASCULAR PROSTHESIS DSY VASCUTEK LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention