BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TEX VASCULAR GRAFT

    MDR report key: 3212764 · Received July 2, 2013

    Report

    Report Number
    2017233-2013-00419
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    January 1, 2001
    Report Date
    June 18, 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 (B)(6), MALE PT UNDERWENT MODIFIED BLALOCK- 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. A RE-DO OF THE 5MM GRAFT TO A 4MM PTFE GRAFT WAS PERFORMED DUE TO THE PT SHOWING FEATURES OF CONGESTIVE HEART FAILURE DUE TO OVERSHUNTING, HAVING NOTHING TO DO WITH AN MANAGEMENT OF THE SEROMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301365 GORE TEX VASCULAR GRAFT DSY/ PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO