BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE

    MDR report key: 1689102 · Received May 11, 2010

    Report

    Report Number
    2017233-2010-00220
    Event Type
    Death
    Date Received
    May 11, 2010
    Date of Event
    April 28, 2010
    Report Date
    May 10, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DYB
    PMA / PMN Number
    K032073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE INSTRUCTIONS FOR USE, THE MINIMUM VESSEL DIAMETER REQUIRED FOR THE 24FR SHEATH IS 8.1 MM.

    Description of Event or Problem · 1

    ON (B) (6) 2010, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A THORACIC AORTIC ANEURYSM USING A GORE CTAG THORACIC ENDOPROSTHESIS. THE PHYSICIAN ACCESSED THE RIGHT EXTERNAL ILIAC ARTERY. DUE TO ANATOMICAL RESTRICTIONS, THE 24FR GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE WAS ADVANCED ONLY 5 CM. THE CTAG DEVICE WAS ADVANCED OUTSIDE OF THE SHEATH AND DEPLOYED WITHOUT INCIDENT. THE PHYSICIAN THEN REMOVED THE GUIDEWIRE, FOLLOWED BY THE REMOVAL OF THE SHEATH. THE REMOVAL OF THE SHEATH RESULTED IN TRAUMATIC DISRUPTION OF THE ILIAC ARTERY. A SURGICAL CUT DOWN WAS PERFORMED IN AN ATTEMPT TO STOP THE BLEEDING. THE PATIENT HAD RECEIVED 5 UNITS OF BLOOD, AND A 8 MM DACRON GRAFT WAS SEWN TO THE RIGHT EXTERNAL ILIAC. POST OPERATIVELY, THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE NONE DYB W.L. GORE & ASSOCIATES WLG340 7639681

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death DURING THE PROCEDURE.| 5000 CC'S OF HEPARIN WERE| 5 UNITS OF BLOOD WERE TRANSFUSED| ADMINISTERED DURING THE PROCEDURE.