BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOSPROSTHESIS

    MDR report key: 3030763 · Received March 27, 2013

    Report

    Report Number
    2017233-2013-00176
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    December 27, 2009
    Report Date
    February 26, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE ARTICLE - "THE OUTCOME OF FAILED ENDOGRAFTS INSERTED FOR SUPERFICIAL FEMORAL ARTERY OCCLUSIVE DISEASE".

    Description of Event or Problem · 1

    AN ARTICLE PUBLISHED BY THE JOURNAL OF VASCULAR SURGERY, 2012.08.068 "THE OUTCOME OF FAILED ENDOGRAFTS INSERTED FOR SUPERFICIAL FEMORAL ARTERY OCCLUSIVE DISEASE". MARE M. A. LENSVELT, MD, A BAHAR GOLCHEHR, MD, A ROMBOUT R. KRUSE, MD, B SUZANNE HOLEWIJN, PHD, A LAURENS A. VAN WALRAVEN, MD, C WILBERT M. FRITSCHY, MD, PHD, B CLARK J. ZEEBREGTS, MD, PHD, D AND MICHEL M. P. J. REIJNEN, MD, PHD, A ARNHEM, ZWOLLE, SNEEK, AND GRONINGEN, THE NETHERLANDS. GORE CONTACTED THE AUTHOR FOR ADDITIONAL INFORMATION. IT WAS REPORTED THAT PT #6 REQUIRED INTERVENTION 20 DAYS POST OP. ADDITIONALLY, IT WAS REPORTED THE PT WAS TREATED BY CATHETER BASED CHEMICAL THROMBOLYSIS. NO LOT NUMBER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125649 GORE VIABAHN ENDOSPROSTHESIS NIP/STENT, SUPERFICIAL FEMORAL ARTERY NIP W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention