BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS

    MDR report key: 1665059 · Received April 20, 2010

    Report

    Report Number
    2017233-2010-00177
    Event Type
    Injury
    Date Received
    April 20, 2010
    Date of Event
    March 18, 2010
    Report Date
    April 20, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE VIABAHN DEVICES REMAIN IMPLANTED. THE VIABAHN DEVICE IMPLANTED MOST DISTALLY AND CLOSEST TO THE REPORTED MARKER WAS THE 6X15 VIABAHN (LOT 6960486; CATALOG VBH061502). A REVIEW OF THE MANUFACTURING RECORDS WAS CONDUCTED. THE REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THE LOT WAS PROCESSED NORMALLY AND ALL PRE-RELEASE SPECIFICATIONS WERE MET. THE FILMS TAKEN DURING THE IMPLANT PROCEDURE WERE REVIEWED. THE REVIEW OF THE AVAILABLE IMAGES DID NOT CONFIRM POST-IMPLANT DEVICE OCCLUSION. A RADIOPAQUE MARKER (TYPE UNK) AT THE LEVEL OF THE RIGHT ANTERIOR TIBIAL ARTERY WAS EVIDENT ON FILMS. CONTRAST APPEARED TO FLOW TO THE LEVEL OF THE MARKER AND DISTAL TO IT.

    Description of Event or Problem · 1

    WITHIN EIGHT DAYS OF IMPLANTATION OF THREE VIABAHN DEVICES (6X15, 6X10, 6X5) FOR TREATMENT OF SFA OCCLUSIVE DISEASE, THE PATIENT RETURNED TO THE IR SUITE WITH A RETURN OF SYMPTOMS TO THE RIGHT LEG. AN ANGIOGRAM WAS PERFORMED AND REVEALED THROMBUS UP TO THE PROFUNDA IN RIGHT LEG. THE VESSEL WAS TREATED WITH POWER PULSE ANGIOJET AND TPA INFUSION TO TREAT THE LOWER LIMB RESIDUAL THROMBUS. THE PHYSICIAN NOTICED A SMALL RADIOPAQUE MARKER IN THE ANTERIOR TIBIAL ARTERY AT THE RUN OFF. THE MARKER WAS LEFT IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE VIABAHN ENDOPROSTHESIS NIP / STENT, SUPERFICIAL FEMORAL ARTERY NIP W.L. GORE & ASSOCIATES WLG335 6960486

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention 5FR COOK SHEATH FOR DIAGNOSTIC AORTA| 0.035 INCH TERUMO GUIDE WIRE WAS ADVANCED ACROSS| IMPLANT PROCEDURE| LESION TO BE ABLE TO TREAT THE LESION.| DEVICES TO THE LESION.| 7FR COOK INTRODUCER SHEATH TO ADVANCE THE VIABAHN| DISEASED VESSEL.| BARD RIVAL 5MMX150MM PTA BALLOON TO DILATE THE