BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE

    MDR report key: 1730504 · Received June 16, 2010

    Report

    Report Number
    2017233-2010-00285
    Event Type
    Injury
    Date Received
    June 16, 2010
    Date of Event
    May 20, 2010
    Report Date
    June 16, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DYB
    PMA / PMN Number
    K032073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. IT WAS REPORTED TO GORE THAT THE LEFT EXTERNAL ILIAC ARTERY WAS 7.4-7.5 MM . THE OUTSIDE DIAMETER FOR A TS2230 DEVICE IS 8.3 MM. THE VESSEL DAMAGE MAY HAVE BEEN DUE TO THE DEVICE OVERSIZING. ACCORDING TO THE GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE INSTRUCTIONS FOR USE (IFU), ILIO-FEMORAL ACCESS VESSEL SIZE AND MORPHOLOGY (E.G., MINIMAL THROMBUS, CALCIUM AND/OR TORTUOSITY) SHOULD BE ADEQUATE TO ACCOMMODATE THE REQUIRED INTRODUCER SHEATH DIAMETERS USING APPROPRIATE VASCULAR ACCESS TECHNIQUES (INCLUDING SURGICAL CONDUIT, IF NEEDED). IF VESSEL IS TOO SMALL, MAJOR BLEEDING, VESSEL RUPTURE/PERFORATION, AND SERIOUS INJURY TO THE PT INCLUDING DEATH MAY RESULT. ADDITIONALLY, THE IFU STATE DO NOT ATTEMPT TO ADVANCE OR WITHDRAW GUIDEWIRE, CATHETER, OR OTHER DEVICE THROUGH THE INTRODUCER SHEATH AND/OR DILATOR IF RESISTANCE IS FELT. USE FLUOROSCOPY TO DETERMINE THE CAUSE. CONTINUED ADVANCEMENT OR RETRACTION AGAINST RESISTANCE MAY RESULT IN SERIOUS INJURY TO THE PT, DAMAGE TO OR BREAKAGE OF THE GUIDEWIRE, CATHETER, OR OTHER DEVICE. ALSO, A PXC121200/6971440 DEVICE WAS IMPLANTED. A SEPARATE MEDWATCH NEEDED TO BE SUBMITTED TO CAPTURE THE GORE EXCLUDER AAA ENDOPROSTHESIS (MEDWATCH# 2953161-2010-00110).

    Description of Event or Problem · 1

    ON (B) (6) 2010, THE PT WAS IMPLANTED WITH TWO GORE TAG THORACIC ENDOPROSTHESES TO TREAT A THORACIC AORTIC ANEURYSM FROM THE ASCENDING AORTA TO THE AORTIC ARCH. THE GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE WAS INSERTED FROM THE LEFT FEMORAL ARTERY AND TWO TAG DEVICES WERE IMPLANTED. WHEN THE INTRODUCER SHEATH WAS REMOVED, THE PHYSICIAN FORCIBLY PULLED IT OUT DESPITE OF STRONG RESISTANCE. THE LEFT EXTERNAL ILIAC ARTERY WAS DAMAGED AND RUPTURED. A CONTRALATERAL LEG COMPONENT WAS IMPLANTED AND A HEMORRHAGE WAS ARRESTED. A BLOOD LOSS WAS LESS THAN 1 LITER. ON (B) (6) 2010, A SURGICAL PROCEDURE WAS PERFORMED. THE PT PRESENTED WITH AN ABDOMINAL DISTENTION AND AN INTRA-ABDOMINAL HEMORRHAGE WAS VISUALLY OBSERVED BETWEEN THE CONTRALATERAL LEG COMPONENT AND THE EXTERNAL ILIAC ARTERY. THE DEVICE WAS REMOVED AND A DACRON VASCULAR GRAFT WAS IMPLANTED. THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE DYB / INTRODUCER, CATHETER DYB W.L. GORE & ASSOCIATES WLG340 7652362

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R