BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® DRYSEAL FLEX INTRODUCER SHEATH

    MDR report key: 13549810 · Received February 17, 2022

    Report

    Report Number
    3007284313-2022-01781
    Event Type
    Injury
    Date Received
    February 17, 2022
    Date of Event
    January 19, 2022
    Report Date
    May 9, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DYB
    UDI-DI
    00733132630073
    PMA / PMN Number
    K160254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CODE "OTHER" WAS SELECTED AS THE MEDICAL DEVICE WAS DISCARDED AT FACILITY. RETURN NOT POSSIBLE. (B)(4).

    Additional Manufacturer Narrative · 0

    CODE "OTHER" WAS SELECTED AS THE MEDICAL DEVICE WAS DISCARDED AT FACILITY. RETURN NOT POSSIBLE. (B)(4).

    Additional Manufacturer Narrative · 0

    ADDED G3/G4, H1/H2, H6: INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2022, THIS PATIENT UNDERWENT AN EMERGENCY ENDOVASCULAR TREATMENT FOR AN AORTIC ARCH ANEURYSM RUPTURE USING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG-AC) AND A GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF). THE PROXIMAL END OF CTAG-AC WAS PLACED JUST DISTAL THE BRACHIOCEPHALIC ARTERY. AN EMBOLIZATION OF THE LEFT SUBCLAVIAN ARTERY AND A DEBRANCHING TECHNIQUE WERE ALSO PERFORMED. THE FINAL ANGIOGRAPHY DURING THE PROCEDURE SHOWED A DISSECTION OF THE DSF ACCESS SITE OF THE RIGHT EXTERNAL ILIAC ARTERY. SINCE THE DISSECTION WAS MINOR, NO TREATMENT WAS GIVEN AND THE PROCEDURE WAS COMPLETED. THE PATIENT TOLERATED THE PROCEDURE.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2022, THIS PATIENT UNDERWENT AN EMERGENCY ENDOVASCULAR TREATMENT FOR AN AORTIC ARCH ANEURYSM RUPTURE USING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG-AC) AND A GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF). THE PROXIMAL END OF CTAG-AC WAS PLACED JUST DISTAL THE BRACHIOCEPHALIC ARTERY. AN EMBOLIZATION OF THE LEFT SUBCLAVIAN ARTERY AND A DEBRANCHING TECHNIQUE WERE ALSO PERFORMED. THE FINAL ANGIOGRAPHY DURING THE PROCEDURE SHOWED A DISSECTION OF THE DSF ACCESS SITE OF THE RIGHT EXTERNAL ILIAC ARTERY. SINCE THE DISSECTION WAS MINOR, NO TREATMENT WAS GIVEN AND THE PROCEDURE WAS COMPLETED. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1917405 GORE® DRYSEAL FLEX INTRODUCER SHEATH INTRODUCER, CATHETER DYB W. L. GORE & ASSOCIATES, INC. DSF2233 00733132630073

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention