BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® DRYSEAL FLEX INTRODUCER SHEATH

    MDR report key: 15550697 · Received October 6, 2022

    Report

    Report Number
    3007284313-2022-02148
    Event Type
    Injury
    Date Received
    October 6, 2022
    Date of Event
    September 8, 2022
    Report Date
    October 6, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DYB
    UDI-DI
    00733132630950
    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

    "OTHER" WAS SELECTED AS THE MEDICAL DEVICE WAS DISCARDED AT FACILITY. RETURN NOT POSSIBLE. W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    ON (B)(6) 2022, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ARCH AND DESCENDING AORTIC ANEURYSM USING 24 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH (SHEATH) WITH 1 DEBRANCH BYPASS. DURING THE TREATMENT, AN ATTEMPT WAS MADE TO ADVANCE THE SHEATH FROM THE LEFT SIDE, HOWEVER, THE SHEATH ADVANCEMENT WAS UNABLE. AN ATTEMPT WAS MADE TO ADVANCE THE SHEATH FROM THE RIGHT SIDE WHERE RESISTANCE WAS FELT BUT THE SHEATH WAS ABLE TO ADVANCE. AFTER ALL STENT GRAFTS WERE IMPLANTED AND THE SHEATH WAS REMOVED, BLOOD FLOW IN RIGHT FEMORAL ARTERY WAS POOR. DIGITAL SUBTRACTION ANGIOGRAPHY REVEALED A DISSECTION AND A CONTRAST LEAKAGE AT THE RIGHT EXTERNAL ILIAC ARTERY. ADDITIONALLY, A STENT GRAFT WAS IMPLANTED AND THE LEAKAGE WAS RESOLVED. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY, THE DIAMETER OF THE RUPTURED ARTERY WAS 9 MM. THE DIAMETER AROUND THE RUPTURED ARTERY WAS 7.5 MM AND 8 MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2888246 GORE® DRYSEAL FLEX INTRODUCER SHEATH INTRODUCER, CATHETER DYB W. L. GORE & ASSOCIATES, INC. DSF2433 00733132630950

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention