BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® DRYSEAL FLEX INTRODUCER SHEATH

    MDR report key: 6005779 · Received October 6, 2016

    Report

    Report Number
    3007284313-2016-00197
    Event Type
    Injury
    Date Received
    October 6, 2016
    Date of Event
    September 8, 2016
    Report Date
    October 10, 2016
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DSF1833 (B)(4). CONCOMITANT MEDICAL PRODUCTS. DSL1828 (B)(4), DSL1828 (B)(4). (BOTH REPORTED SEPARATELY). PMA/510K NUMBER: K160254. (B)(4).

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE GORE® DRYSEAL FLEX SHEATH INSTRUCTIONS FOR USE, ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO, BLOOD LOSS AND BLEEDING.

    Description of Event or Problem · 1

    ON (B)(6) 2016 A PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM WITH A 28.5X14.5X12 GOREEXCLUDER AAA ENDOPROSTHESIS FEATURING C3 DELIVERY SYSTEM. THE PATIENT REPORTEDLY HAD A SHORT, HIGHLY ANGULATED AORTIC NECK, DESCRIBED AS 90 DEGREES LEFT TO RIGHT. AN 18FR GORE DRYSEAL FLEX SHEATH WAS USED FOR ACCESS. WHILE THE TRUNK-IPSILATERAL LEG COMPONENT WAS BEING ADVANCED THROUGH THE SHEATH, THE VALVE OF THE SHEATH DEFLATED. ATTEMPTS WERE MADE TO CLOSE THE VALVE BY TWISTING AND CLAMPING, BUT THESE ATTEMPTS WERE UNSUCCESSFUL. THIS SHEATH WAS EXCHANGED FOR A NEW SHEATH,(GORE DRYSEAL SHEATH), WHICH RESULTED IN THE SAME SCENARIO. A THIRD SHEATH(GOREDRYSEAL SHEATH), WAS INTRODUCED WHICH ALSO RESULTED IN THE SAME SCENARIO. THE TRUNK IPSILATERAL LEG COMPONENT WAS EVENTUALLY DEPLOYED. THE PATIENT'S ESTIMATED BLOOD LOSS WAS 300CC. THE PATIENT WAS GIVEN 1.5 UNITS OF A BLOOD REPLACEMENT PRODUCT. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655277 GORE® DRYSEAL FLEX INTRODUCER SHEATH INTRODUCER, CATHETER DYB W.L. GORE & ASSOCIATES 317621

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| O| R