BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TEX® VASCULAR GRAFT

    MDR report key: 3831602 · Received May 26, 2014

    Report

    Report Number
    2017233-2014-00273
    Event Type
    Injury
    Date Received
    May 26, 2014
    Date of Event
    January 1, 2014
    Report Date
    April 28, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K802095
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IN REVIEW OF PUBLISHED LITERATURE, THESE FINDINGS WERE NOTED: MIN BAO, PH.D., HONGYIN LI, M.D., GUANGYU PAN, M.D., ZHONGHUA XU, M.D. AND QINGYU WU, M.D., "CENTRAL SHUNT PROCEDURES FOR COMPLEX CONGENITAL HEART DISEASES", J CARD SURG 2014;XX:1-5 PUBLISHED ONLINE 2014, DOI: 10.1111/JOCS.12343. BETWEEN APRIL 2004 AND NOVEMBER 2012, TOTAL 110 PATIENTS (MEDIAN AGE,11 MONTHS; MEDIAN WEIGHT, 9 KG) WITH THE COMPLEX CONGENITAL HEART DISEASES WERE TREATED WITH THE GORE-TEX GRAFTS IN THE SHUNT OPERATION, THE GRAFT SIZE WAS DETERMINED PRIMARILY BASED ON THE PATIENTS' BODY WEIGHT PRIOR TO THE OPERATIONS. THE ARTICLE DESCRIBES ONE PATIENT DEVELOPED A SHUNT OCCLUSION REQUIRING A SECOND OPERATION AT DAY 5 FOLLOWING WHICH THE PATIENT EXPERIENCED CONTINUOUS RIGHT LUNG HEMORRHAGE AND DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309943 GORE TEX® VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention