BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TEX® VASCULAR GRAFT

    MDR report key: 3831633 · Received May 26, 2014

    Report

    Report Number
    2017233-2014-00272
    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 ACUTE GRAFT OCCLUSION OCCURRED IN ONE PATIENT (5-MM SHUNT SIZE), WHICH WAS IDENTIFIED BY A DECREASE IN OXYGEN SATURATION AND ECHOCARDIOGRAPHY SHOWING NO SHUNT FLOW AT DAY 10 AND DAY 30 AFTER THE SHUNT PROCEDURE. THE PATIENT UNDERWENT A SECOND OPERATION WITH A SATISFACTORY OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309923 GORE TEX® VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention