BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE DRYSEAL SHEATH

    MDR report key: 2062673 · Received April 11, 2011

    Report

    Report Number
    2017233-2011-00181
    Event Type
    Injury
    Date Received
    April 11, 2011
    Date of Event
    March 18, 2011
    Report Date
    April 11, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DYB
    PMA / PMN Number
    K093791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. RESULTS: THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. PRE-IMPLANT IMAGES SHOWED THE PT'S RIGHT EXTERNAL ILIAC DIAMETER TO RANGE FROM 4.4-6.7MM WITH SIGNIFICANT CALCIFICATION. THE OUTER DIAMETER OF THE 18FR GORE DRYSEAL SHEATH IS 6.8MM. THE GORE DRYSEAL SHEATH INSTRUCTIONS FOR USE (IFU) WARNS "ADEQUATE VESSEL ACCESS IS REQUIRED TO INTRODUCE THE SHEATH INTO THE VASCULATURE. CAREFUL EVALUATION OF VESSEL SIZE, ANATOMY, TORTUOSITY, 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 PT, INCLUDING DEATH, MAY RESULT." THE IFU CONTINUES TO STATE "IF VESSEL SIZE IS SMALLER THAN THE INTRODUCER SHEATH OUTER DIAMETER MAJOR BLEEDING, VESSEL DAMAGE, OR SERIOUS INJURY TO THE PT, INCLUDING DEATH, MAY RESULT." VASCULAR TRAUMA (I.E., DISSECTION, RUPTURE, PERFORATION, TEAR, ETC.) IS LISTED IN THE IFU AS A POTENTIAL ADVERSE EVENT THAT MAY OCCUR AND/OR REQUIRE INTERVENTION. ATTEMPT TO ACQUIRE INFORMATION REQUIRED FOR THIS FORM WERE MADE BY GORE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE, OR WAS NOT APPLICABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PHYSICIAN PLANNED ON TREATING THE PT WITH THE GORE EXCLUDER AAA ENDOPROSTHESIS FOR AN ABDOMINAL AORTIC ANEURYSM. THE PT WAS NOT A CANDIDATE FOR OPEN REPAIR. PRE-TREATMENT IMAGES SHOWED THE PT HAD NARROW HEAVILY CALCIFIED VESSELS OUTSIDE OF THE GORE DRYSEAL SHEATH TREATMENT DIAMETERS AND THE PHYSICIAN ANTICIPATED DIFFICULT SHEATH ACCESS. THE PHYSICIAN USED A 6 MM AND THEN 8 MM EV3 PTA BALLOONS TO DILATE THE RIGHT FEMORAL ARTERY TO ACCESS AN 18FR SHEATH. DURING INSERTION OF THE 18 FR SHEATH THE FEMORAL ARTERY RUPTURED. THE PHYSICIAN ANTICIPATED THIS AND HAD PREVIOUSLY ADVANCED A COOK BALLOON UP THE LEFT SIDE TO PREVENT ANY BLOOD LOSS AND THE ARTERY WAS SUCCESSFULLY REPAIRED WITH A VEINUS PATCH AND THE ANEURYSM TREATMENT WAS ABANDONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE DRYSEAL SHEATH DYB / INTRODUCER, CATHETER DYB W.L. GORE & ASSOCIATES WLG401 8246126

    Patients

    Seq Age Sex Outcome Treatment
    1 Other