BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN® ENDOPROSTHESIS

    MDR report key: 6055905 · Received October 25, 2016

    Report

    Report Number
    2017233-2016-00821
    Event Type
    Injury
    Date Received
    October 25, 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: TWO GORE® VIABAHN® ENDOPROSTHESIS WERE IMPLANTED DURING THE PROCEDURE. IT IS UNCLEAR WHICH DEVICE WAS ASSOCIATED WITH THE RUPTURED ARTERY. NO SPECIFIC DEVICE INFORMATION WAS PROVIDED. THEREFORE, REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED AND NO UDI IS AVAILABLE. THE DEVICES WERE 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 #2 THE PSEUDOANEURYSM RUPTURED AFTER PLACEMENT OF THE SECOND GORE® VIABAHN® ENDOPROSTHESIS. THE ARTICLE STATED THAT THE ARTERY RUPTURED DISTALLY FROM THE EDGE OF THE GORE® VIABAHN® ENDOPROSTHESIS AND THE HEMORRHAGE WAS CONTROLLED BY MEANS OF A 5MM X 20MM BALLOON CATHETER THAT WAS IMMEDIATELY INFLATED AT THE RUPTURE SITE. ACCORDING TO THE ARTICLE, REPAIR USING THE GORE® VIABAHN® ENDOPROSTHESIS WAS DENIED BECAUSE OF TORTUOUS ANATOMY OF THE HEPATIC ARTERY. THE PATIENT WAS TRANSFERRED TO SURGERY, AND THE ANEURYSM WAS SUCCESSFULLY TREATED SURGICALLY. THE ARTICLE REPORTED THAT NO FURTHER EPISODES OF HEMORRHAGE WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704202 GORE VIABAHN® ENDOPROSTHESIS STENT, SUPERFICIAL FEMORAL ARTERY NIP W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention