BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS

    MDR report key: 10354730 · Received August 3, 2020

    Report

    Report Number
    2017233-2020-01072
    Event Type
    Injury
    Date Received
    August 3, 2020
    Date of Event
    January 1, 2020
    Report Date
    August 3, 2020
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    PFV
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED AS DEVICE ITEM/LOT NUMBERS WERE NOT AVAILABLE. THE IMAGES AND DEVICE WERE NOT AVAILABLE, THE IMAGING EVALUATION AND ENGINEERING EVALUATION COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    THE FOLLOWING PUBLICATION WAS REVIEWED: "RETROSPECTIVE EVALUATION OF THE ENDOVASCULAR REPAIR OF THE ANASTOMOTIC PSEUDOANEURYSM OF THE TRANSPLANTED RENAL ARTERY USING THE SNORKEL TECHNIQUE" THROUGH "VASCULAR 0(0) 1¿6 THE AUTHOR(S) 2020". THE AUTHORS ARE CHE HAIJIE, SONG FUBO, LI XIAOYING, YU YING AND PU ZENGHUI. THE ARTICLE AIMED TO EVALUATE THE ENDOVASCULAR REPAIR OF THE TRANSPLANTED RENAL ARTERY ANASTOMOTIC PSEUDOANEURYSM USING THE SNORKEL TECHNIQUE. FROM APRIL 2012 TO DECEMBER 2017, WE PERFORMED ENDOVASCULAR REPAIR IN SIX PATIENTS, WHO WERE DIAGNOSED WITH TRANSPLANTED RENAL ARTERY ANASTOMOTIC PSEUDOANEURYSM, USING THE SNORKEL TECHNIQUE. THE ¿SNORKEL¿ STENT AND THE ¿PARALLEL¿ STENT WERE PLACED IN THE TRANSPLANTED KIDNEY AND THE EXTERNAL ILIAC ARTERY, RESPECTIVELY. ANOTHER COVERED STENT WAS IMPLANTED AT THE PROXIMAL END OF THE EXTERNAL ILIAC ARTERY TO MATCH THE DIAMETER OF THE ILIAC ARTERY. IN THE FIRST PATIENT, FLUENCY STENTS WERE USED, AND IN THE REMAINING FIVE PATIENTS, VIABAHN STENTS (GORE, INC., FLAGSTAFF, ARIZONA) WERE USED. REPORTED RESULTS STATED ONE PATIENT (CASE NO. 5) DEVELOPED STENT THROMBOSIS AND RENAL FAILURE FOUR MONTHS AFTER THE SURGERY. ALTHOUGH THE TRUNK AND BRANCHES OF THE RENAL ARTERY WERE RESTORED THROUGH THROMBOLYSIS, THE TRANSPLANTED KIDNEY WAS NOT RESCUED DUE TO THE EXTENSIVE OBSTRUCTION OF SMALL BLOOD VESSELS IN THE RENAL PARENCHYMA (FIGURE 3). NEPHRECTOMY WAS SUBSEQUENTLY PERFORMED. THE STENTS WERE REMOVED, AND THE ILIAC ARTERY WAS REPAIRED DURING THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820513 GORE VIABAHN ENDOPROSTHESIS ENDOVASCULAR GRAFT, ARTERIOVENOUS DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT PFV W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention