BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TEX VASCULAR GRAFT

    MDR report key: 3212752 · Received July 2, 2013

    Report

    Report Number
    2017233-2013-00422
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    January 1, 2001
    Report Date
    June 8, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K802095
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: NO ACTUAL EVENT DATE WAS PROVIDED. THEREFORE, DATE OF EVENT IS AN ESTIMATE BASED ON PUBLICATION DATE OF THE ARTICLE.

    Description of Event or Problem · 1

    SAHOO M, SAHU M, KALE S, SAXENA N. SEROUS FLUID LEAKAGE FOLLOWING MODIFIED BLALOCK-TAUSSIG OPERATION USING PTFE GRAFTS. INDIAN HEART J 2001;53:328-331. THE ARTICLE STATES THAT A 5 YEAR OLD, MALE PT UNDERWENT MODIFIED BALALOCK- TAUSSIG SHUNT USING GORE- TEX VASCULAR GRAFT FOR TREATMENT OF CONGENITAL HEART DEFECTS. THE PT PRESENTED WITH RESPIRATORY DISTRESS BETWEEN 2 AND 12 WEEKS OF SHUNT SURGERY. INITIAL MANAGEMENT WAS CONSERVATIVE (BY PHARMACOLOGICAL MEANS AND TUBE THORACTOSTOMY). REOPERATION WAS UNDERTAKEN WHEN THE CONSERVATIVE TREATMENT FAILED. RE-EXPLORATION CONFIRMED THE DIAGNOSIS OF A PERIGRAFT SEROUS EFFUSION. THE SHUNT WAS FOUND TO BE PATENT. THE SEROMA WAS CLEARED AND TOPICAL FIBRIN GLUE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301364 GORE TEX VASCULAR GRAFT DSY/PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention