BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN® ENDOPROSTHESIS - 3

    MDR report key: 8057389 · Received November 9, 2018

    Report

    Report Number
    2017233-2018-00672
    Event Type
    Injury
    Date Received
    November 9, 2018
    Date of Event
    January 1, 2017
    Report Date
    November 13, 2018
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    PFV
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. RESULTS CODE 1: 213: A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE DEVICES MET PRE-RELEASE SPECIFICATIONS. A REVIEW OF THE STERILIZATION RECORDS CONFIRMED THAT ALL LOTS MET ALL PRE-RELEASE STERILIZATION SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: 'PET CT TO CONFIRM AN INFECTED POPLITEAL STENT GRAFT USED TO TREAT POPLITEAL ARTERY ANEURYSM' (STUART WALKER, M.D.; EUR J VASC ENDOVASC SURG (2017) 54, 612) CONCOMITANT MEDICAL PRODUCTS. ADDITIONAL DEVICES: PAH111002 UDI: (B)(4); PAH110502 UDI: (B)(4). IT IS NOT KNOWN WHICH DEVICE(S) BECAME OCCLUDED/INFECTED, THEREFORE ALL WERE INCLUDED IN THE INVESTIGATION.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: IN AN ABSTRACT 'PET CT TO CONFIRM AN INFECTED POPLITEAL STENT GRAFT USED TO TREAT POPLITEAL ARTERY ANEURYSM' (STUART WALKER, M.D.; EUR J VASC ENDOVASC SURG (2017) 54, 612) WAS REVIEWED. THE ABSTRACT DISCUSSES A VIABAHN IMPLANT, AND FOCUSES ON THE CASE 4 YEARS POST IMPLANT. IT IS IDENTIFIED THAT 4 YEARS POST IMPLANT THE STENT OCCLUDED, BUT THIS WAS ASSOCIATED WITH MILD CLAUDICATION AND WAS MANAGED CONSERVATIVELY. TWO MONTHS LATER, THE PATIENT PRESENTED WITH A LEFT POPLITEAL ABSCESS; DRAINAGE YIELDED PROTEUS MIRABILIS. FOLLOWING ORAL COTRIBOXAZOLE TREATMENT, THE PATIENT IS ASYMPTOMATIC BUT HAS DECLINED REMOVAL OF THE INFECTED STENT GRAFT. IN COMMUNICATION WITH THE AUTHOR, THE DATE OF IMPLANT WAS (B)(6) 2012. THERE WAS NO PRE-EXISTING INFECTION. THE PATIENT'S LEG IS CURRENTLY INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896477 GORE VIABAHN® ENDOPROSTHESIS - 3 NIP PFV W.L. GORE & ASSOCIATES 8942360

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| O| R