BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TEX® VASCULAR GRAFT

    MDR report key: 5567927 · Received April 11, 2016

    Report

    Report Number
    2017233-2016-00345
    Event Type
    Injury
    Date Received
    April 11, 2016
    Date of Event
    July 1, 2004
    Report Date
    March 16, 2016
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K802095
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS FROM THE FOLLOWING LITERATURE ARTICLE: DEMIRCIN M, DOÐAN R, ÖZKAN M, ÖZSOY F, KUZGUN E, GÜVENER M. PERIGRAFT SEROMA COMPLICATING THE MODIFIED BLALOCK-TAUSSIG SHUNTS: TWO CONSECUTIVE INSTANCES WITH REVIEW OF LITERATURE. TURK J PEDIATR 2004; 46: 275-278. DATE OF EVENT REFLECTS DATE OF PUBLICATION WHICH WAS JULY - SEPTEMBER 2004. NO LOT NUMBER INFORMATION WAS SUPPLIED; THEREFORE, NO REVIEW OF THE MANUFACTURING PAPERWORK COULD BE PERFORMED. THE DEVICE REMAINED IMPLANTED; CONSEQUENTLY, A DIRECT PRODUCT ANALYSIS WAS NOT POSSIBLE.

    Description of Event or Problem · 1

    IN THE MEDICAL LITERATURE, AN ARTICLE, "PERIGRAFT SEROMA COMPLICATING THE MODIFIED BLALOCK-TAUSSIG SHUNTS: TWO CONSECUTIVE INSTANCES WITH REVIEW OF LITERATURE" WAS REVIEWED. A SINGLE STAGE SURGICAL REPAIR WAS PLANNED FOR A (B)(6) BOY WITH TETRALOGY OF FALLOT. A LEFT MODIFIED B-T SHUNT WAS THEN PERFORMED WITH A 5 MM THIN-WALLED GORE-TEX® VASCULAR GRAFT CONFIGURED FOR PEDIATRIC SHUNTS. EARLY POSTOPERATIVE PERIOD WAS UNEVENTFUL, AND THE DRAINAGE TUBE WAS REMOVED ON THE SECOND POSTOPERATIVE DAY. THE PATIENT DEVELOPED RESPIRATORY DISTRESS ON THE FIFTH DAY. CHEST X-RAY REVEALED LEFT SUPERIOR MEDIASTINAL MASS. THORACAL COMPUTERIZED TOMOGRAPHY (CT) DEMONSTRATED PERIGRAFT SEROMA. RE-THORACOTOMY WAS PERFORMED AND THE CLEAR AND GELATINOUS SEROMA MATERIAL WAS REMOVED AND SILICONE DRAINAGE TUBE WAS REPLACED. THE LUNG FULLY RE-EXPANDED SOON AFTER SURGERY AND THE PATIENT WAS KEPT UNDER CONTROLLED VENTILATION FOR ONE DAY. THE COMPOSITION OF THE DRAINAGE CHANGED TO CHYLOUS IN NATURE ON THE THIRD POSTOPERATIVE DAY AND CONTINUED FOR SEVEN MORE DAYS (200 CC/DAY). DIETARY CONTROL AND CONTINUOUS INTRAVENOUS SOMATOSTATIN INFUSION CONTROLLED THE DRAINAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223402 GORE TEX® VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Required Intervention