BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE DRYSEAL SHEATH

    MDR report key: 3021549 · Received March 12, 2013

    Report

    Report Number
    3007284313-2013-00012
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 15, 2013
    Manufacturer
    W. L. GORE ASSOCIATES
    Product Code
    DYB
    PMA / PMN Number
    K093791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. CONCLUSIONS - THE GORE DRYSEAL SHEATH WITH HYDROPHILIC COATING INSTRUCTIONS FOR USE (IFU) STATE THAT ADEQUATE VESSEL ACCESS IS REQUIRED TO INTRODUCE THE SHEATH INTO THE VASCULATURE. CAREFUL EVALUATION OF VESSEL SIZE AND DISEASE STATE (INCLUDING CALCIFICATION, PLAQUE, AND THROMBUS) IS REQUIRED TO ENSURE SUCCESSFUL SHEATH INTRODUCTION AND SUBSEQUENT WITHDRAWAL. IF VESSEL IS NOT ADEQUATE FOR ACCESS, MAJOR BLEEDING, VESSEL DAMAGE, OR SERIOUS INJURY TO THE PATIENT, INCLUDING DEATH, MAY RESULT. IF THE VESSEL SIZE IS SMALLER THAN THE INTRODUCER SHEATH OUTER DIAMETER (9.1 MM FOR A 24 FR SHEATH), THEN VESSEL DAMAGE MAY RESULT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE WITH GORE TAG THORACIC ENDOPROSTHESIS TO TREAT A THORACIC AORTIC ANEURYSM. AT THE END OF THE PROCEDURE, AFTER THE ANEURYSM WAS EXCLUDED, THE PHYSICIAN BEGAN TO WITHDRAW THE GORE DRYSEAL SHEATH WITH HYDROPHILIC COATING (DSL2428/10913158) FROM THE RIGHT ILIAC ARTERY. IT WAS DISCOVERED THAT THE RIGHT ILIAC ARTERY RUPTURED. A GORE VIABAHN ENDOPROSTHESES WAS USED TO REPAIR THE ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE. THE RIGHT ILIAC ARTERY MEASUREMENT WAS 8 MM AND WAS VERY DISEASED. IT WAS REPORTED THE PATIENT HAD EXTREME CALCIUM, THROMBUS, AND TORTUOSITY IN THE VESSELS. BLOOD LOSS WAS 1000 CC. IT WAS REPORTED ON (B)(6) 2013, THE PATIENT WAS EXPERIENCING PARAPLEGIA. THE PHYSICIAN IS NOT ATTRIBUTING THIS TO THE RUPTURE ILIAC, BUT IS ATTRIBUTING THE PARAPLEGIA CAUSE FROM THE PREVIOUSLY IMPLANTED AAA GRAFT (BRAND IS ENDOLOGIX).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104326 GORE DRYSEAL SHEATH DYB / INTRODUCER, CATHETER DYB W. L. GORE ASSOCIATES 10913158

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention TUBASTATIN| REMAPRIL| LEVOTHYROXINE| ASPIRIN| LOW PRESSOR| NORVASC