BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TEX VASCULAR GRAFT

    MDR report key: 3221072 · Received July 2, 2013

    Report

    Report Number
    2017233-2013-00421
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    January 1, 2001
    Report Date
    June 18, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    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

    ATTACHED ARTICLE: SEROUS FLUID LEAKAGE FOLLOWING MODIFIED BLALOCK-TAUSSIG OPERATION USING PTFE GRAFTS; INDIAN HEART J 2001; 53:328-331; MANORANJAN SAHOO, MANOJ SAHU, SHAILAJA KALE, NITA SAXENA.

    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 3 YEAR OLD, FEMALE PATIENT UNDERWENT MODIFIED BALALOCK-TAUSSIG SHUNT USING GORE-TEX VASCULAR GRAFT FOR TREATMENT OF CONGENITAL HEART DEFECTS. THE PATIENT PRESENTED WITH RESPIRATORY DISTRESS BETWEEN 2 AND 12 WEEKS OF SHUNT SURGERY. INITIAL MANAGEMENT WAS CONSERVATIVE (BY PHARMACOLOGICAL MEANS AND TUBE THORACOSTOMY). 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
    302422 GORE TEX VASCULAR GRAFT DSY/PROSTHESIS DSY W.L. GORE & ASSOCIATES,INC

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention