BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN® ENDOPROSTHESIS

    MDR report key: 6059036 · Received October 26, 2016

    Report

    Report Number
    2017233-2016-00827
    Event Type
    Injury
    Date Received
    October 26, 2016
    Date of Event
    November 29, 2015
    Report Date
    October 2, 2016
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: NO SPECIFIC DEVICE INFORMATION WAS PROVIDED. THEREFORE, REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED AND NO UDI IS AVAILABLE. THE DEVICE WAS NOT RETURNED. CONSEQUENTLY, DIRECT PRODUCT ANALYSIS WAS NOT POSSIBLE. ADDITIONAL INFORMATION ABOUT THIS EVENT COULD NOT BE OBTAINED. AS A RESULT, NO FURTHER INVESTIGATION IS POSSIBLE. ALL INFORMATION HAS BEEN PLACED ON FILE FOR USE IN TRACKING AND TRENDING.

    Description of Event or Problem · 1

    DURING REVIEW OF THE ARTICLE (ACCEPTED MANUSCRIPT: AUTHORS: F. PEDERSOLI, P. ISFORT, S. KEIL, F. GOERG, M. ZIMMERMANN, M. LIEBL, M. SCHULZE-HAGEN, M. SCHMEDING, C. K. KUHL, P. BRUNERS; STENTGRAFT IMPLANTATION FOR THE TREATMENT OF POSTOPERATIVE HEPATIC ARTERY PSEUDOANEURYSM; CARDIOVAS INTERVENT RADIOL (2016) 39:575-581, DOI 10.1007/S00270-015-1274-1 IT WAS OBSERVED IN CASE #7 THAT FOLLOW-UP CT IMAGING 3 DAYS POST IMPLANT OF THE GORE VIABAHNENDOPROSTHESIS & ATRIUM ADVANTA COVERED STENT, CLINICALLY ASYMPTOMATIC COMPLETE OCCLUSION OF THE STENT GRAFT WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709297 GORE VIABAHN® ENDOPROSTHESIS STENT, SUPERFICIAL FEMORAL ARTERY NIP W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention