BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE-TEX® VASCULAR GRAFT

    MDR report key: 24436909 · Received February 24, 2026

    Report

    Report Number
    2017233-2026-07192
    Event Type
    Injury
    Date Received
    February 24, 2026
    Date of Event
    April 2, 2025
    Report Date
    February 24, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DYF
    PMA / PMN Number
    K802095
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE REVIEWED: OUTCOMES AND PREDICTORS OF FAILURE OF SYSTEMIC-TO-PULMONARY SHUNTS: EXPERIENCE OF A SINGLE INSTITUTION OVER 14 YEARS. HANNAH O DAVIS, ET AL. WORLD JOURNAL FOR PEDIATRIC AND CONGENITAL HEART SURGERY 2025, VOL. 16(6) 801-809. ACCEPTED APRIL 2, 2025. MEDIAN AGE AND GENDER WERE OBTAINED FROM LITERATURE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN DETAILS FROM AUTHOR. HOWEVER, NO RESPONSE WAS RECEIVED. A UNIQUE DEVICE IDENTIFICATION NUMBER WAS NOT PROVIDED. THEREFORE, THE MANUFACTURING DATE AND/OR PRODUCTION DETAILS CANNOT BE DETERMINED. NEITHER IMAGES ENABLING DIRECT ASSESSMENT OF PRODUCT PERFORMANCE NOR THE PRODUCT ITSELF, WHICH REMAINS IMPLANTED, WERE RETURNED FOR EVALUATION. BASED ON LITERATURE INFORMATION, AN ADDITION MANUFACTURING REPORT #2017233-2026-07179 WAS SUBMITTED SEPARATELY. W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    LITERATURE REVIEWED: OUTCOMES AND PREDICTORS OF FAILURE OF SYSTEMIC-TO-PULMONARY SHUNTS: EXPERIENCE OF A SINGLE INSTITUTION OVER 14 YEARS. HANNAH O DAVIS, ET AL. WORLD JOURNAL FOR PEDIATRIC AND CONGENITAL HEART SURGERY 2025, VOL. 16(6) 801-809. ACCEPTED APRIL 2, 2025. FROM JANUARY 2009 TO DECEMBER 2022, 287 PATIENTS WHO UNDERWENT SA-PA SHUNTS WERE INCLUDED, WHILE PATIENTS WHO UNDERWENT A NORWOOD PROCEDURE, RV-PA SHUNT, OR FENESTRATED PATCH WERE EXCLUDED. SHUNTS WERE PLACED AT A MEDIAN OF 15.0 DAYS. OF THE 287 PATIENTS, 178 THORACOTOMY APPROACHES WERE USED, AND 109 STERNOTOMY APPROACH FOR THE REST OF THE PATIENTS. CARDIOPULMONARY BYPASS (CPB) WAS PERFORMED FOR 46 OF 287 CASES. NEXT STAGE SURVIVAL WAS 246 OUT OF 275, IN-HOSPITAL MORTALITY 18/287 AND INTERSTAGE MORTALITY 12/287. LITERATURE STATES SHUNT FAILURE IS A MAJOR CONTRIBUTOR TO MORBIDITY AND MORTALITY, WITH RISK FACTORS INCLUDING PREOPERATIVE HYPERCOAGULABILITY, SMALLER SHUNT SIZE, AND COMPETITIVE PULMONARY BLOOD FLOW. GORE-TEX® VASCULAR GRAFT OR GORE® PROPATEN® VASCULAR GRAFT (GRAFT/SHUNT) WERE IMPLANTED. FOR HEPARIN COATED GRAFTS, 199 WERE USED. GRAFT SIZES WERE 3MM (2), 3.5MM (128), 4MM (153), AND 5MM (4). OF 287 PATIENTS, 179 HAD CONCURRENT PROCEDURES PERFORMED. SOME PATIENTS UNDERWENT MORE THAN ONE CONCURRENT PROCEDURE. SHUNTS WERE BEVELED, AND ANASTOMOSES WERE END-TO-SIDE USING 8-0 GORE-TEX SUTURE. SHUNT PROXIMAL ANASTOMOSIS WAS THE AORTA, LEFT SUBCLAVIAN ARTERY, LEFT INNOMINATE ARTERY, RIGHT INNOMINATE ARTERY, RIGHT SUBCLAVIAN ARTERY, RIGHT CAROTID ARTERY, WHILE SHUNT DISTAL ANASTOMOSIS WAS LEFT PULMONARY ARTERY, RIGHT PULMONARY ARTERY, AND THE MAIN PULMONARY ARTERY. SHUNT-RELATED COMPLICATIONS INCLUDED 21 SHUNT THROMBOSIS, 18 SHUNT STENOSIS, 6 SHUNT OBSTRUCTION, 30 SHUNT-RELATED PULMONARY BRANCH STENOSIS, 43 PULMONARY OVERCIRCULATION, 28 EARLY SHUNT FAILURE (MEDIAN 38 DAYS), AND 9 SHUNT OUTGROWTHS. SHUNT-RELATED REINTERVENTIONS INCLUDE 28 PULMONARY ARTERIOPLASTY OR BALLOON DILATION, 27 SHUNT REVISION OR PLACEMENT OF SECOND SHUNT, 15 CATHETER-BASED STENT INSERTION OR BALLOON DILATION OF SHUNT, AND 7 TREATMENTS OF OVERCIRCULATION (REQUIRED SHUNT BANDING AND URGENT CATHETER-BASED COILING OF MAJOR AORTOPULMONARY COLLATERAL ARTERIES). EARLY REINTERVENTION TOTALED 30 (MEDIAN 4.7 MONTHS). MAJOR COMPLICATIONS INCLUDED 24 OF 287 POSTOPERATIVE MECHANICAL CIRCULATION. REINTERVENTION WAS REQUIRED IN 77 OUT OF 287 PATIENTS (44 DUE TO SHUNT FAILURE AND 28 FOR PA STENOSIS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201557 GORE-TEX® VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER DYF W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 15 DA Male Other| R