BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS

    MDR report key: 11721092 · Received April 23, 2021

    Report

    Report Number
    2017233-2021-01898
    Event Type
    Injury
    Date Received
    April 23, 2021
    Date of Event
    November 27, 2020
    Report Date
    October 4, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    PRL
    PMA / PMN Number
    P160021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED WITH ADDITIONAL INFORMATION: PATIENT INFORMATION FIELDS A2 AND A3 WERE UPDATED TO REFLECT THE MEAN PATIENT AGE OF 74 YEARS AND PREDOMINANTLY MALE STUDY COHORT (95%).

    Additional Manufacturer Narrative · 1

    CBAS® HEPARIN SURFACE INCORPORATES CBAS-HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS REVIEWED BY GORE: "RENAL STENT COMPLICATIONS AND IMPACT ON RENAL FUNCTION AFTER STANDARD FENESTRATED ENDOVASCULAR ANEURYSM REPAIR." AUTHORS: CELINE DESLARZES-DUBUIS, KENNETH TRAN, BENJAMIN D. COLVARD, JASON T. LEE, ANNALS OF VASCULAR SURGERY, VOLUME 72, 2021, PAGES 106-113. A 60 TOTAL OF GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) AND 133 ICAST DEVICES WERE UTILIZED AS BRIDGING STENTS. 17 TOTAL RENAL STENT-RELATED COMPLICATIONS WERE REPORTED INCLUDING STENT OCCLUSIONS (N=4), STENOSIS (N=9), DISLOCATION (N=3), AND ENDOLEAK (N=1). ALL STENT COMPLICATIONS UNDERWENT REINTERVENTION WITH A TECHNICAL SUCCESS OF 94.2%. PATIENTS WITH OCCLUSION WERE TREATED THE DAY OF DIAGNOSIS WITH A MEAN TIME FROM DIAGNOSIS TO REINTERVENTION OF 21.5 DAYS. THE STUDY CONCLUDES WITH STATING THAT: "FEVAR IS A DURABLE OPTION FOR THE TREATMENT OF JUXTARENAL AORTIC ANEURYSMS AND IS ASSOCIATED WITH EXCELLENT SECONDARY PATENCY. RENAL STENT COMPLICATIONS HAVE NO SIGNIFICANT IMPACT ON RENAL FUNCTION, BUT SMALLER NATIVE RENAL ARTERIES ARE AT HIGHER RISK OF STENT-GRAFT COMPLICATIONS." THIS CASE IS COVERING THE FOLLOWING ALLEGATIONS (NONE OF WHICH HAVE SPECIFICALLY IDENTIFIED A VBX DEVICE AS THE MEDICAL DEVICE ASSOCIATED WITH THE ALLEGATION): OCCLUSION AND STENOSIS WITH REPORTED REINTERVENTION, DEVICE MIGRATION WITH REPORTED REINTERVENTION, AND AN ENDOLEAK WITH A REPORTED REINTERVENTION. THIS REPORT IS COVERING THE ALLEGATION OF AN ENDOLEAK WITH REPORTED REINTERVENTION. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615494 GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS ILIAC COVERED STENT, ARTERIAL PRL W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R