BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 12561411 · Received October 1, 2021

    Report

    Report Number
    2017233-2021-02425
    Event Type
    Injury
    Date Received
    October 1, 2021
    Date of Event
    September 7, 2021
    Report Date
    October 1, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 LITERATURE WAS REVIEWED: ¿CONSIDERATION ABOUT TWO CASES WHICH WERE PERFORMED SURGICAL TREATMENT FOR INFECTION OF VIABAHN STENT GRAFT AFTER EVT¿ (JUN OKATOME, ET AL., JOURNAL OF THE JAPANESE SOCIETY FOR VASCULAR SURGERY, 2021: 30(SUPPL.) P.O48-4) A (B)(6)-YEAR-OLD WOMAN WHO HAD TYPE 2 DIABETES UNDERWENT ENDOVASCULAR TREATMENT OF BILATERAL PERIPHERAL ARTERIAL DISEASE USING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN) DEVICE AT ANOTHER MEDICAL INSTITUTION. THE VIABAHN DEVICE WAS IMPLANTED IN THE BILATERAL SUPERFICIAL FEMORAL ARTERY. AT POSTOPERATIVE THREE MONTHS, A PAIN IN THE LEFT FEMORAL AREA WAS REPORTED, AND AN INCREASE IN INFLAMMATORY RESPONSE WAS OBSERVED. AN EXAMINATION REVEALED A SUSPECTED ABSCESS FORMATION AROUND THE LEFT SUPERFICIAL FEMORAL ARTERY STENT GRAFT. ANTIBIOTIC THERAPY WAS PERFORMED BUT DID NOT IMPROVE THE SYMPTOMS, THEREFORE THE INFECTED VIABAHN DEVICE WAS REMOVED SURGICALLY AND A BYPASS OF THE LEFT FEMORAL ARTERY-ABOVE-KNEE POPLITEAL ARTERY WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1461170 GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| O