BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE-TEX VASCULAR GRAFT

    MDR report key: 11980732 · Received June 10, 2021

    Report

    Report Number
    2017233-2021-02069
    Event Type
    Injury
    Date Received
    June 10, 2021
    Date of Event
    January 4, 2011
    Report Date
    July 19, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DSY
    PMA / PMN Number
    K802095
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE CITATION: THE LITERATURE NAME: ¿SURGICAL MANAGEMENT OF PULMONARY ATRESIA WITH VENTRICULAR SEPTAL DEFECT: EARLY TOTAL CORRECTION VERSUS SHUNT¿ PUBLISHED BY THE SOCIETY OF THORACIC SURGEONS, ANN THORAC SURG 2011;91:1928 ¿35. ACCEPTED FOR PUBLICATION JAN 4, 2011. THE AUTHORS: (B)(6) HOSPITAL, BUCHEON, REPUBLIC OF KOREA DOI:10.1016/J.ATHORACSUR.2011.01.014.

    Additional Manufacturer Narrative · 1

    DUE TO AN UNKNOWN LOT/SERIAL NUMBER AND NO DEVICE RETURN, AN INVESTIGATION COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED THROUGH LITERATURE SURGICAL MANAGEMENT OF PULMONARY ATRESIA WITH VENTRICULAR SEPTAL DEFECT: EARLY TOTAL CORRECTION VERSUS SHUNT PUBLISHED BY THE SOCIETY OF THORACIC SURGEONS, ANN THORAC SURG 2011;91:1928 35. THE STUDY WAS TO COMPARE THE SURGICAL OUTCOMES OF SHUNT AND EARLY TOTAL CORRECTION. FROM 1997 TO 2008, 47 PATIENTS WITH PULMONARY ATRESIA WITH VENTRICULAR SEPTAL DEFECT AND NO MAJOR AORTOPULMONARY COLLATERAL ARTERIES WHO UNDERWENT SURGICAL CORRECTION WERE ENROLLED IN THIS RETROSPECTIVE STUDY. TWENTY-NINE PATIENTS UNDERWENT PALLIATIVE SHUNT OPERATION (GROUP S). THE MOST COMMONLY USED SHUNT SIZE WAS 3.5 MM IN DIAMETER (N=17) AND THIS WAS FOLLOWED BY A 4-MM SIZE SHUNT (N=8) WITH A GORE-TEX VASCULAR GRAFT (W.L. GORE ASSOC. INC, ELKTON, MD). THE RESULTS STATE THAT IN TERMS OF COMPLICATIONS, IN THE SHUNT GROUP, DURING THE FOLLOW-UP DURATION, 10 ADDITIONAL SHUNT OPERATIONS WERE REQUIRED IN 8 OF 29 PATIENTS IN THIS GROUP BEFORE THE TOTAL CORRECTION DUE TO DYSFUNCTION OF SHUNT AND SEVERE HYPOXIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876011 GORE-TEX VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER DSY W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 40 DA Required Intervention