BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEALPTFE

    MDR report key: 490845 · Received October 10, 2003

    Report

    Report Number
    9612515-2003-00016
    Event Type
    Other
    Date Received
    October 10, 2003
    Date of Event
    August 25, 2003
    Report Date
    October 8, 2003
    Manufacturer
    VASCUTEK LTD.
    Product Code
    DSY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PROCEDURE WAS PROLONGED DUE TO THE INTERVENTION REQUIRED. DURING AN ELECTIVE PROCEDURE TO PERFORM AN AXILLO-FEMORAL CROSSOVER BYPASS USING AN EXTERNALLY SUPPORTED VASCULAR PROSTHESIS. THE AXILLAR ANASTOMOSIS HAD ALREADY BEEN MADE AND THE PROSTHESIS HAD BEEN TUNNELLED AND CUT TO LENGTH. WHEN CAREFULLY REMOVING THE REINFORCEMENT RINGS TO MAKE THE DISTAL ANASTOMOSIS. THE PROSTHESIS TORE. THE PROSTHESIS WAS REPAIRED WITH SEVERAL SINGLE STITCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEALPTFE VASCULAR PROSTHESIS DSY VASCUTEK LTD. NA P04569/0

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention