BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® DRYSEAL FLEX INTRODUCER SHEATH

    MDR report key: 15533723 · Received October 3, 2022

    Report

    Report Number
    3007284313-2022-02141
    Event Type
    Injury
    Date Received
    October 3, 2022
    Date of Event
    June 7, 2019
    Report Date
    March 10, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132629961
    PMA / PMN Number
    K160254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED BY THE GORE STUDY MANAGER. THERE WERE NO ANATOMY ANOMALIES. INJURY TO THE RIGHT EXTERNAL ILIAC ARTERY WAS A RUPTURE. THERE WAS NO INJURY TO THE RIGHT EXTERNAL ILIAC ARTERY PRIOR TO THE PROCEDURE. THE DOCTOR STATED, "THE EXACT ROOT CAUSE IS NOT KNOWN, BUT HE SUSPECTS IT IS AN INJURY FROM THE SHEATH AT AN AREA OF CALCIFICATION." YES, THE SHEATH EVENT LEAD TO THE INJURY OF THE RIGHT EXTERNAL ILIAC ARTERY. D12-THE GORE® DRYSEAL FLEX INTRODUCER SHEATH INSTRUCTIONS FOR USE (IFU) STATES ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE BUT ARE NOT LIMITED TO VASCULAR TRAUMA.

    Description of Event or Problem · 0

    THE PATIENT REFERENCED IN THIS EVENT FILE IS ENROLLED IN A POST MARKET STUDY: AAA 13-03 CEXC; THE CLINICAL DATA MANAGEMENT SYSTEM (CDMS), IS MEDIDATA RAVE® CLINICAL STUDY DATABASE (CSD). THE STUDY INVOLVES COMMERCIALLY AVAILABLE DEVICES MARKETED BY GORE. THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2019, A PATIENT UNDERWENT TREATMENT OF A 60 MM ABDOMINAL AORTIC ANEURYSM WITH A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES. DURING THE IMPLANT PROCEDURE WHILE UTILIZING THE 12 FR DRYSEAL FLEX INTRODUCER SHEATH A RIGHT EXTERNAL ILIAC ARTERY INJURY OCCURRED. A STENT GRAFT SELF-EXPANDING WAS IMPLANTED, THE INJURY WAS RESOLVED. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2928696 GORE® DRYSEAL FLEX INTRODUCER SHEATH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. DSF1233 00733132629961

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Hospitalization