BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® INTRODUCER SHEATH WITH SILICONE PINCH VALVE

    MDR report key: 5210744 · Received November 9, 2015

    Report

    Report Number
    2017233-2015-00763
    Event Type
    Injury
    Date Received
    November 9, 2015
    Date of Event
    October 28, 2010
    Report Date
    November 24, 2015
    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

    ADDITIONAL MANUFACTURER NARRATIVE - THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2010, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF TWO SEPARATE THORACIC AORTIC ANEURYSMS USING THREE GORE® TAG® THORACIC ENDOPROSTHESES (TGT3420/7813424, TGT4020/8325102, TGT4020/8138151) AND THREE STENT-GRAFTS (MANUFACTURER UNKNOWN). PRIOR TO THE IMPLANTATION, A RIGHT SUBCLAVIAN ARTERY TO RIGHT COMMON CAROTID ARTERY TO LEFT COMMON CAROTID ARTERY BYPASS WAS PERFORMED. A GORE® INTRODUCER SHEATH WITH SILICONE PINCH VALVE (TS2430/ 8130708) WAS INSERTED FROM THE PATIENT'S RIGHT SIDE AND THE DEVICES WERE IMPLANTED WITHOUT ANY REPORTED ISSUES. REMOVAL OF THE SHEATH RESULTED IN TRAUMATIC INJURY TO THE RIGHT ILIAC ARTERY. THE DIAMETER OF THE RIGHT EXTERNAL ILIAC ARTERY WAS 8 MM. THE INJURY WAS REPAIRED WITH A STENT-GRAFT (MANUFACTURER UNKNOWN) AND A VASCULAR GRAFT (MANUFACTURER UNKNOWN). THE PATIENT TOLERATED THE PROCEDURE. THE TOTAL AMOUNT OF BLOOD LOSS DURING THE PROCEDURE WAS 3000 ML. ON THE SAME DAY OF THE PROCEDURE, THE PATIENT SUFFERED A STROKE. NO INDICATION WAS GIVEN AS TO THE POTENTIAL CAUSE OF THE STROKE. THE PATIENT WAS TREATED WITH MEDICATION. (THIS PORTION OF THE EVENT WAS REPORTED ON MFR REPORT # 2017233-2015-00762) ON (B)(6) 2010, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH REMAINING SYMPTOMS OF THE STROKE. ON (B)(6) 2013, COMPLETE RECOVERY FROM THE STROKE WAS CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740033 GORE® INTRODUCER SHEATH WITH SILICONE PINCH VALVE INTRODUCER, CATHETER DYB W.L. GORE & ASSOCIATES 8130708

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other| R