BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 10458325 · Received August 27, 2020

    Report

    Report Number
    2017233-2020-01184
    Event Type
    Injury
    Date Received
    August 27, 2020
    Date of Event
    June 11, 2019
    Report Date
    January 6, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - THE ITEM NUMBER AND LOT NUMBER OF THE DEVICE COULD NOT BE PROVIDED, SO NO MANUFACTURING EVALUATION COULD NOT BE PERFORMED. (B)(4) -THE DEVICE REMAINS IMPLANTED. THEREFORE, DIRECT PRODUCT ANALYSIS WAS NOT POSSIBLE.

    Description of Event or Problem · 1

    THE FOLLOWING PUBLICATION WAS REVIEWED: " A SINGLE CENTER EXPERIENCE OF IN SITU NEEDLE FENESTRATION OF SUPRA-AORTIC BRANCHES DURING THORACIC ENDOVASCULAR AORTIC REPAIR" RECEIVED THROUGH "ANN VASC SURG 2019; 61: 107¿115" . THE AUTHORS: YILANG XIANG, CHENYANG QIU, YANGYAN HE, DONGLIN LI, TAO SHANG, ZIHENG WU, AND HONGKUN ZHANG. THE ARTICLE AIMED TO REPORT THE EARLY RESULTS AND TECHNICAL DETAILS OF IN SITU NEEDLE FENESTRATION DURING THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR). THIRTY-SEVEN PATIENTS WITH THORACIC AORTIC DISEASE WHO UNDERWENT TEVAR WITH IN SITU NEEDLE FENESTRATION IN OUR DEPARTMENT BETWEEN FEBRUARY 2016 AND APRIL 2017 WERE INCLUDED IN THIS STUDY. THEIR DEMOGRAPHIC INFORMATION, CLINICAL MANIFESTATIONS, PERIPROCEDURAL OUTCOMES, AND FOLLOW-UP RESULTS WERE ANALYZED. THUS, THE BALLOON WAS DEPLOYED, AND VIABAHN STENTS (W.L. GORE ASSOCIATES, INC, FLAGSTAFF, AZ) WERE IMPLANTED. GIVEN THAT EXPANDABLE BALLOON-COVERED STENTS WERE UNAVAILABLE IN OUR CENTER, WE USED SELF EXPANDING VIABAHN STENTS AND A MUSTANG BALLOON (BOSTON SCIENTIFIC, JAPAN) FOR POSTDILATION. REPORTED RESULTS STATED IN ONE CASE, THE BRANCH STENT GRAFT STUCK IN THE BRACHIAL ARTERY AND WAS SURGICALLY REMOVED. THE PHYSICIANS ONCE ADVANCED A STENT GRAFT THROUGH A SHORT SHEATH. AS A RESULT, THE STENT GRAFT BECAME STUCK IN THE PATIENT¿S BRACHIAL ARTERY, AND AN EXTENDED INCISION OF THE ARTERY WAS PERFORMED TO REMOVE THE STENT GRAFT. A LONG SHEATH WAS THEN REINSERTED TO DELIVER THE STENT TO THE CORRECT PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923511 GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention