BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEALPTFE THINWALL

    MDR report key: 469919 · Received July 3, 2003

    Report

    Report Number
    9612515-2003-00011
    Event Type
    Other
    Date Received
    July 3, 2003
    Date of Event
    June 10, 2003
    Report Date
    July 3, 2003
    Manufacturer
    VASCUTEK LTD.
    Product Code
    DSY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE EVENT OCCURRED DURING AN ELECTIVE FEMEROL POPLITEAL PROCEDURE TO IMPLANT AN EXTERNALLY SUPPORTED VASCULAR PROSTHESIS. THE SURGEON TOOK A 60CM GRAFT AND CUT TO 40CM TO FACILITATE THE ACCURATE REPLACEMENT OF THE DISEASED ARTERY. HE THEN UNWRAPPED THE SUPPORT AND SUCCESSFULLY COMPLETED THE DISTAL ANASTOMOSIS. WHEN PREPARING THE PROXIMAL END, HE UNWRAPPED THE SUPPORT AND THE GRAFT TORE. THE PROCEDURE WAS PROLONGED AS THE SURGEON CUT OFF THE DAMAGED SECTION, SUTURED THE OFF-CUT ONTO THE GRAFT AND THEN SUCCESSFULLY COMPLETED THE PROXIMAL ANASTOMOSIS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, THE PT SUFFERED NO ILL EFFECTS AND WAS DISCHARGED AS PER NORMAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEALPTFE THINWALL VASCULAR PROSTHESIS DSY VASCUTEK LTD. NA P04348/5

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention