BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE DRYSEAL SHEATH

    MDR report key: 2234083 · Received August 29, 2011

    Report

    Report Number
    2017233-2011-00443
    Event Type
    Injury
    Date Received
    August 29, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 26, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DYB
    PMA / PMN Number
    K093791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LOT/SERIAL NUMBER IS NOT AVAILABLE TO CONDUCT A MFG RECORDS REVIEW. A MFG RECORDS REVIEW WAS NOT CONDUCTED. THE SIZING TABLE OF THE GORE DRYSEAL SHEATH INSTRUCTIONS FOR USE SPECIFIES THAT THE 20 FR SHEATH HAS A MINIMUM INNER DIAMETER (ID) OF 6.8 MM AND A NOMINAL OUTER DIAMETER (OD) OF 7.5 MM. CAREFUL EVAL OF VESSEL SIZE, ANATOMY, TORTUOSITY, AND DISEASE STATE (INCLUDING CALCIFICATION, PLAQUE, AND THROMBUS) IS REQUIRED TO ENSURE SUCCESSFUL SHEATH INTRODUCTION AND SUBSEQUENT WITHDRAWAL. ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO, VASCULAR TRAUMA (I.E., DISSECTION, RUPTURE, PERFORATION, TEAR, ETC.), BLOOD LOSS, AND DEATH.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESES FEATURING THE C3 DELIVERY SYSTEM. THE ILIAC ARTERIES WERE SMALL, MEASURING 6-7 MM. THE ANEURYSM WAS EXCLUDED; HOWEVER, THE LEFT EXTERNAL ILIAC ARTERY WAS TORN UPON REMOVING THE 20 FR GORE DRYSEAL SHEATH. THE LEFT EXTERNAL ILIAC ARTERY AND LEFT COMMON ILIAC ARTERY WERE LIGATED AND A FEMORAL-TO-FEMORAL CROSSOVER WAS PERFORMED. TOTAL BLOOD LOSS WAS ABOUT 1 LITER. THE PT TOLERATED THE PROCEDURE WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R HYZAAR| CARDEZEM| ZOCOR| DILTIAZEM