BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS - 3

    MDR report key: 10049838 · Received May 12, 2020

    Report

    Report Number
    2017233-2020-00355
    Event Type
    Injury
    Date Received
    May 12, 2020
    Date of Event
    February 24, 2018
    Report Date
    July 7, 2020
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    PFV
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H6: CONCLUSIONS CODE 1: CODE 4315 - AS THE DEVICE WAS NOT AVAILABLE FOR RETURN, AND NO EVALUATION OF THE DEVICE COULD BE PERFORMED, CAUSE WAS UNABLE TO BE ESTABLISHED. H6: DEVICE CODE 1: UPDATED DEVICE CODE. LOT/SERIAL NUMBERS WERE NOT PROVIDED, THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED, THEREFORE THIS EVENT IS BEING CLOSED WITH THE AVAILABLE INFORMATION. IT SHOULD BE NOTED THAT THE GORE® VIABAHN® ENDOPROSTHESIS INSTRUCTIONS FOR USE ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: "COMPLICATIONS AND ADVERSE EVENTS CAN OCCUR WHEN USING ANY ENDOVASCULAR DEVICE. THESE COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO: HEMATOMA; STENOSIS, THROMBOSIS OR OCCLUSION; DISTAL EMBOLISM; SIDE BRANCH OCCLUSION; VESSEL WALL TRAUMA AND / OR RUPTURE; FALSE ANEURYSM; INFECTION; INFLAMMATION; FEVER AND / OR PAIN IN THE ABSENCE OF INFECTION; DEPLOYMENT FAILURE; MIGRATION; AND DEVICE FAILURE."

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURER NARRATIVE: NO ACTUAL EVENT DATE WAS PROVIDED. THEREFORE, DATE OF EVENT IS AN ESTIMATE BASED ON PUBLICATION DATE OF THE ARTICLE (02/24/2018).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS IN PROGRESS. SEE MFR REPORT #2017233-2020-00284 FOR INTERVENTION FOR BILATERAL GROIN SEROMA INVESTIGATION. SEE MFR REPORT #2017233-2020-00286 FOR PULMONARY EMBOLUS INVESTIGATION. SEE MFR REPORT #2017233-2020-00285 FOR PSEUDOANEURYSM.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS REVIEWED: 'HYBRID REVASCULARIZATION COMBINING ILIOFEMORAL ENDARTERECTOMY AND ILIAC STENT GRAFTING FOR TRANSATLANTIC INTER-SOCIETY CONSENSUS C AND D AORTOILIAC OCCLUSIVE DISEASE'; JULIET J. RAY, SARAH A. EIDELSON, CHARLES A. KARCUTSKIE, JONATHAN P. MEIZOSO,HILENE DEAMORIM, LEE J. GOLDSTEIN, JOHN KARWOWSKI, AND ARASH BORNAK; ANN VASC SURG 2018; 50: 73¿79; HTTPS://DOI.ORG/10.1016/J.AVSG.2017.11.061; PUBLISHED BY ELSEVIER INC.; MANUSCRIPT RECEIVED: JULY 24, 2017; MANUSCRIPT ACCEPTED: NOVEMBER 19, 2017; PUBLISHED ONLINE: 24 FEBRUARY 2018. THE PURPOSE OF THE STUDY WAS A RETROSPECTIVE REVIEW EXAMINING THE OUTCOMES OF HYBRID REVASCULARIZATION COMBINING ILIOFEMORAL ENDARTERECTOMY AND ILIAC ARTERY STENTING USING COVERED STENTS IN TRANSATLANTIC INTER-SOCIETY CONSENSUS (TASC) C AND D AORTOILIAC OCCLUSIVE DISEASE (AIOD) INVOLVING THE COMMON FEMORAL ARTERY (CFA). ALL EXTERNAL ILIAC ARTERIES WERE TREATED USING A GORE® VIABAHN® ENDOPROSTHESIS. THE ARTICLE IDENTIFIES ON PAGE 77 AN EXPLANT OF THE INFECTED ILIAC STENT AND IN-SITU FEMORAL VEIN BYPASS REVASCULARIZATION, THIS INFECTION PRESENTED 2 MONTHS AFTER AN INITIAL SURGICAL SITE SEROMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513106 GORE VIABAHN ENDOPROSTHESIS - 3 NIP PFV W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other