BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TEX® VASCULAR GRAFT

    MDR report key: 5567902 · Received April 11, 2016

    Report

    Report Number
    2017233-2016-00346
    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. IT WAS STATED THAT A (B)(6) GIRL WAS ADMITTED WITH THE DIAGNOSIS OF TETRALOGY OF FALLOT AND PULMONARY ATRESIA WITH CONFLUENT PULMONARY ARTERY BRANCHES. A PALLIATIVE MODIFIED B-T SHUNT WAS PLANNED BECAUSE PULMONARY VASCULATURE WAS HYPOPLASTIC. A 5 MM GORE-TEX VASCULAR GRAFT CONFIGURED FOR PEDIATRIC SHUNTS WAS INTERPOSED BETWEEN THE RIGHT SUBCLAVIAN AND RIGHT PULMONARY ARTERIES THROUGH A RIGHT POSTEROLATERAL THORACOTOMY. TEN HOURS AFTER THE OPERATION, A CONSOLIDATION WAS OBSERVED IN THE RIGHT UPPER ZONE ON CHEST X-RAY. THIS IMAGE PERSISTED AND BECAME LARGER DESPITE CONTROLLED VENTILATION. THE PATIENT UNDERWENT RETHORACOTOMY ON THE SAME DAY BECAUSE OF A PROBABLE HEMATOMA FORMATION AROUND THE ANASTAMOSES. A RIGHT SUPERIOR MEDIASTINAL MASS OF 6 TO 8 CM IN SIZE SURROUNDING THE FUNCTIONAL GRAFT WAS EXPLORED. THE CLEAR, GELATINOUS MATERIAL WITH A FINE CAPSULE WAS ASPIRATED AND REMOVED BUT THE GRAFT CONTINUED WEEPING COLORLESS SERUM. A THIN SHEATH OF SURGICELL WAS WRAPPED AROUND THE GRAFT. TWO SILICONE DRAINAGE TUBES WERE PLACED IN THE RIGHT PLEURAL CAVITY. THE AMOUNT OF DRAINAGE DECREASED SLOWLY AND CEASED ON THE THIRD POSTOPERATIVE DAY. THE PATIENT HAD AN UNEVENTFUL RECOVERY AND WAS DISCHARGED ON THE SEVENTH POSTOPERATIVE DAY. EVENTUAL FOLLOW-UP CHEST X-RAY SHOWED NO EVIDENCE OF FLUID COLLECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224345 GORE TEX® VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Required Intervention