BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS - 3

    MDR report key: 9123117 · Received September 26, 2019

    Report

    Report Number
    2017233-2019-00926
    Event Type
    Injury
    Date Received
    September 26, 2019
    Date of Event
    October 5, 2018
    Report Date
    September 6, 2019
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    PFV
    PMA / PMN Number
    P130006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE NO PATIENT ID IS AVAILABLE, THE GORE EVENT NUMBER WAS USED AS THE PATIENT IDENTIFIER. THE PATIENT AGE AND PATIENT GENDER REFLECT THE MEAN AGE AND GENDER STATED IN THE ARTICLE. THE DATE OF ONLINE PUBLICATION WAS USED AS THE EVENT DATE. LOT/SERIAL NUMBERS WERE NOT PROVIDED, THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED.

    Description of Event or Problem · 1

    THE FOLLOWING PUBLICATION WAS REVIEWED: ¿VIABAHN STENT GRAFT COMPARED WITH PROSTHETIC SURGICAL ABOVE-KNEE BYPASS IN TREATMENT OF SUPERFICIAL FEMORAL ARTERY DISEASE¿ (NARGES WAEZI, MEDICINE (2018) 97, PUBLISHED ONLINE 05-OCT-2018). RECORDS OF 52 PATIENTS (60 LIMBS), WHO WERE TREATED BY A PROSTHETIC SURGICAL ABOVE-KNEE BYPASS (PAKB) (29 LIMBS) OR GORE VIABAHN® ENDOPROSTHESIS (31 LIMBS) IMPLANTATION IN THE SUPERFICIAL FEMORAL ARTERY BETWEEN 2005 AND 2011 WERE REVIEWED. IN ALL PATIENTS, CONSERVATIVE THERAPY WAS MAXED OUT. ALL PATIENTS SUFFERED FROM CHRONIC ISCHEMIA AND WERE CATEGORIZED BY RUTHERFORD CATEGORIES BASED ON SYMPTOMS AND CLINICAL PRESENTATION AT THE TIME OF THE REVASCULARIZATION. THE ARTICLE INCLUDES THE FOLLOWING CASES IN THE VIABAHN GROUP: AMONG OTHER REPORTED STENT GRAFT FAILURES, IT WAS STATED THAT TWO STENT-GRAFT FAILURES OCCURRED DURING THE FIRST MONTH AFTER IMPLANTATION DUE TO THROMBOSIS. THE ARTICLE IS NOT SPECIFIC ON HOW THE TWO PATIENTS WERE TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916478 GORE VIABAHN ENDOPROSTHESIS - 3 NIP PFV W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention