BEUDAMED
    FDA Adverse Event Other Summary report: N

    EPTFE

    MDR report key: 509365 · Received January 26, 2004

    Report

    Report Number
    9612515-2004-00001
    Event Type
    Other
    Date Received
    January 26, 2004
    Date of Event
    December 12, 2003
    Report Date
    January 26, 2004
    Manufacturer
    VASCUTEK LTD.
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE EVENT DID NOT LEAD TO EITHER A DEATH OR SERIOUS INJURY. THE REASON FOR REPORTING THIS INCIDENT IS THE INTERVENTION REQUIRED TO PREVENT A SERIOUS INJURY. THE INITIAL PROCEDURE OCCURRED IN 2003 AND INVOLVED IMPLANTING AN EXPANDED PTFE VASCULAR PROSTHESIS DURING AN ACROSS KNEE FEMORAL BY-PASS. ELEVEN MONTHS LATER THERE WAS A RE-INTERVENTION DUE TO THE PRESENCE OF A HEMATOMA. IT WAS FOUND THAT THE SUTURE OF THE DISTAL ANASTOMOSIS HAD TORN OUT. THE SURGEON CUT OFF THE SECTION OF THE GRAFT AND ADDED A SECTION OF ANOTHER VASCUTEK PTFE GRAFT TO REMAKE THE DISTAL ANASTOMOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPTFE VASCULAR PROSTHESIS DSY VASCUTEK LTD. NA P04289/IA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention