BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE-TEX STRETCH VASCULAR GRAFT

    MDR report key: 12341267 · Received August 19, 2021

    Report

    Report Number
    2017233-2021-02285
    Event Type
    Injury
    Date Received
    August 19, 2021
    Date of Event
    October 18, 2019
    Report Date
    August 19, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DSY
    PMA / PMN Number
    K933943
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS REVIEWED BY GORE: TITLE: MIDAORTIC SYNDROME DUE TO TAKAYASU ARTERITIS IN A CHILD WITH ACUTE DECOMPENSATED CARDIAC FAILURE MANAGED BY AN EMERGENCY AXILLO-EXTERNAL ILIAC ARTERY BYPASS: A FOLLOW-UP CASE REPORT OF LONG-TERM OUTCOMES SOURCE: ANN VASC SURG 2020; 64: 408.E5¿408.E9. THIS ARTICLE PRESENTS THE CASE OF AN (B)(6) GIRL WHO DEVELOPED ACUTE DECOMPENSATED CARDIAC, RESPIRATORY, AND RENAL FAILURES BECAUSE OF AN OCCLUSION OF THE DESCENDING AORTA SECONDARY TO TAKAYASU ARTERITIS (TA). ALTHOUGH THORACOABDOMINALEAORTIC BYPASS IS USUALLY PERFORMED FOR PATIENTS WITH MAS, THE PROCEDURE WAS CONSIDERED TOO INVASIVE, GIVEN THE PATIENT¿S CONDITION. THEREFORE, AN EMERGENCY AXILLO-EXTERNAL ILIAC ARTERY BYPASS FOR REVASCULARIZATION WAS PERFORMED. SUBSEQUENTLY, ORGAN FAILURE IMPROVED AND SHE WAS DISCHARGED. AT POSTOPERATIVE 10 YEARS, AN ASYMPTOMATIC PSEUDOANEURYSM WAS DETECTED AT THE DISTAL ANASTOMOSIS, FOR WHICH REVISION SURGERY WAS PERFORMED. OVERALL, THE LONG-TERM PROGNOSIS WAS SATISFACTORY, SUGGESTING THAT THIS PROCEDURE IS LESS INVASIVE AND EFFECTIVE FOR TREATMENT OF MAS DUE TO TA, IN EMERGENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241471 GORE-TEX STRETCH VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER DSY W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Hospitalization| O