BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEALPTFE

    MDR report key: 478435 · Received August 4, 2003

    Report

    Report Number
    9612515-2003-00014
    Event Type
    Other
    Date Received
    August 4, 2003
    Date of Event
    July 15, 2003
    Report Date
    August 4, 2003
    Manufacturer
    VASCUTEK LTD.
    Product Code
    DSY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE EVENT DID NOT LEAD TO EITHER A DEATH OR A SERIOUS INJURY. THE PATIENT'S CONDITION WAS CONSIDERED FINE THE DAY AFTER THE PROCEDURE. THE EVENT OCCURRED DURING AN ELECTIVE PROCEDURE TO CREATE A CROSS-OVER FEMORO-POPLITEAL BY-PASS USING A SEALPTFE VASCULAR PROSTHESIS REINFORCED WITH A POLYPROPYLENE SUPPORT. THE SURGEON WAS EXPERIENCING DIFFICULTY WHILST TUNNELING THE GRAFT THROUGH VERY FIBROUS TISSUE. THE SPIRAL OF THE GRAFT HAD NOT BEEN ABLE TO GO THROUGH THE TUNNEL DUE TO THE RESISTANCE ENCOUNTERED. THE SPIRAL DETACHED AND CAUSED THE GRAFT TO TEAR TWICE AND SPLIT INTO 3 PIECES. THE SURGEON THEN STARTED THE PROXIMAL ANASTOMOSIS USING THE SEALPTFE, HE JOINED A GORE GRAFT ONTO THE SEALPTFE. WHICH HE THEN USED TO COMPLETE THE ANSTOMOSIS AT THE DISTAL END. THE INCIDENT IS BEING REPORTED DUE TO THE INTERVENTION REQUIRED WHEN CREATING THE VASCUTEK SEALPTFE AND GORE ANASTOMOSIS, WHICH LED TO THE SUBSEQUENT PROLONGATION OF THE PROCEDURE. THE COMPLETED ADVERSE EVENT FORM INDICATES THAT THE SURGEON BELIEVED THE INCIDENT TO BE BOTH PROCEDURE AND DEVICE RELATED. THE DOCTOR REPORTED THAT THE PATIENT HAS HAD A HISTORY OF CARDIOVASCULAR OPERATIONS HAVING PREVIOUSLY UNDERGONE BOTH AN AORTO BIFEMORAL PROCEDURE AND A FEMORO-POPLITEAL BY-PASS. THEREFORE, THE ROUTE TO TUNNEL FOR THE GRAFT WAS VERY FIBROUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEALPTFE VASCULAR PROSTHESIS DSY VASCUTEK LTD. NA P03233/0

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention