BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE DRYSEAL FLEX INTRODUCER SHEATH

    MDR report key: 10697621 · Received October 19, 2020

    Report

    Report Number
    2017233-2020-01363
    Event Type
    Injury
    Date Received
    October 19, 2020
    Date of Event
    September 24, 2020
    Report Date
    March 10, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DYB
    PMA / PMN Number
    K160254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    G3/G4: REVISED PMA/510K NUMBER TO K160254.

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE GORE® DRYSEAL SHEATH WITH HYDROPHILIC COATING INSTRUCTIONS FOR USE, ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO, VASCULAR TRAUMA.

    Description of Event or Problem · 1

    ON (B)(6) 2020, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC ANEURYSM USING A GORE® DRYSEAL FLEX INTRODUCER SHEATH AS AN ACCESSORY IN THE PROCEDURE. 2 DEBRANCH BYPASS, AND CHIMNEY GRAFTING FOR THE BRACHIOCEPHALIC ARTERY WERE ALSO PERFORMED. IT WAS REPORTED THAT THERE WAS A RESISTANCE WHEN DELIVERING THE 22 FR SHEATH INSERTING FROM THE RIGHT SIDE OF THE PATIENT. AFTER IMPLANTATION OF STENT GRAFTS, THE ACCESS ANGIOGRAPHY SHOWED A LOCALIZED DISSECTION AT THE RIGHT COMMON ILIAC ARTERY. NO TREATMENT WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE, AND THE PHYSICIAN WILL CONTINUE TO MONITOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1165763 GORE DRYSEAL FLEX INTRODUCER SHEATH INTRODUCER, CATHETER DYB W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization