BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS

    MDR report key: 6985720 · Received October 27, 2017

    Report

    Report Number
    2017233-2017-00565
    Event Type
    Injury
    Date Received
    October 27, 2017
    Date of Event
    May 27, 2016
    Report Date
    December 7, 2017
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    PFV
    PMA / PMN Number
    P130006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    UPDATED MODEL # AND NAME, ADDRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE GORE® VIABAHN® ENDOPROSTHESIS INSTRUCTIONS FOR USE STATES, SPECIAL CARE SHOULD BE TAKEN TO ENSURE THAT THE APPROPRIATE SIZE ENDOPROSTHESIS, COMPATIBLE SHEATH AND GUIDEWIRE ARE SELECTED PRIOR TO INTRODUCTION. NATIVE VESSEL DIMENSIONS MUST BE ACCURATELY MEASURED, NOT ESTIMATED. LITERATURE CITATION: MASSIERE B ET AL. 2016 "TEN-YEAR EXPERIENCE WITH MANAGEMENT OF AORTOILIAC ANEURYSMS USING RETROGRADE ENDOVASCULAR INTERNAL ILIAC ARTERY PRESERVATION" ANN VASC SURG 2016; 35: 163-167.

    Description of Event or Problem · 1

    IN A LITERATURE ARTICLE TITLED "TEN-YEAR EXPERIENCE WITH MANAGEMENT OF AORTOILIAC ANEURYSMS USING RETROGRADE ENDOVASCULAR INTERNAL ILIAC ARTERY PRESERVATION" IT STATES GORE® VIABAHN® ENDOPROSTHESES WERE UTILIZED IN CONJUNCTION WITH APOLLO AORTOMONOILIAC DEVICES ON THE CONTRALATERAL SIDE, POSITIONED FROM THE EXTERNAL ILIAC ARTERY INTO THE INTERNAL ILIAC ARTERY AS A BRIDGING STENT AND FEMOROFEMORAL BYPASS. TYPE IB ENDOLEAK ASSOCIATED WITH THE VIABAHN WAS DIAGNOSED IN 1 PATIENT. SUBSEQUENT EVALUATION REVEALED THAT THE VIABAHN WAS UNDERSIZED FOR EXTERNAL ILIAC ARTERY AND ANOTHER PROCEDURE WAS PERFORMED TO IMPLANT A LARGER VIABAHN DISTALLY. A VIABAHN OCCLUSION WAS DIAGNOSED IN 1 PATIENT, AT ON MONTH. THIS PATIENT HAD A 4-MM IIA AND A 5-MM VIABAHN IMPLANTED. THIS PATIENT DID NOT EXHIBIT SYMPTOMS OF PELVIC ISCHEMIA. THIS EVENT ADDRESSES THE TYPE IB ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765332 GORE® VIABAHN® ENDOPROSTHESIS NIP PFV W.L. GORE & ASSOCIATES 7627119

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| O| R