BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEALPTFE

    MDR report key: 486606 · Received September 23, 2003

    Report

    Report Number
    9612515-2003-00015
    Event Type
    Other
    Date Received
    September 23, 2003
    Date of Event
    July 25, 2003
    Report Date
    September 23, 2003
    Manufacturer
    VASCUTEK LTD.
    Product Code
    DYF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE EVENT OCCURRED DURING AN ELECTIVE PROCEDURE TO USE A PTFE POLYPROPYLENE SPIRAL SUPPORTED GRAFT ON THE RIGHT ILIOPROFUNDA. INTERVENTION AND SUBSEQUENT PROLONGATION OF THE PROCEDURE, OCCURRED WHEN THE SURGEON WAS REQUIRED TO CREATE TWO SEPARATE ANASTOMOSES; ONE WITH THE DEVICE BEING REPORTED AND ONE WITH A SECOND PTFE GRAFT FOLLOWED BY AN EXTRA ANATOMICAL BY-PASS TO ENABLE HIM TO COMPLETE THE PROCEDURE. FOLLOWING AN ILIAC ANASTOMOSIS. THE PTFE POLYPROYLENE SPIRAL SUPPORTED GRAFT WAS BEING TUNNELLED RETROPERITONEALLY, WHILE PREPARING FOR THE PROFUNDA ANASTOMOSIS. THE SPIRAL SUPPORT WAS REMOVED AND THE GRAFT TORE AT THE SUPPORTED AREA. THE SURGEON REMOVED THE DAMAGED PART OF THE IMPLANTED GRAFT AND THEN USED A NEW SPIRAL SUPPORTED PTFE GRAFT TO CREATE AN ANASTOMOSIS TO THEIN-SITU GRAFT. FOLLOWING THIS THE DR ANASTOMISED THE PTFE GRAFT TO COMPLETE THE PROCEDURE TO THE PROFUNDA ARTERY. BLOOD LOSS FOR THE PROCEDURE WAS LESS THAN 200ML AND 500ML OF HEPARIN WAS USED DURING THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEALPTFE VASCULAR PROSTHESIS DYF VASCUTEK LTD. NA P04702/B

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention