BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® DRYSEAL FLEX INTRODUCER SHEATH

    MDR report key: 15199987 · Received August 10, 2022

    Report

    Report Number
    3007284313-2022-02075
    Event Type
    Death
    Date Received
    August 10, 2022
    Date of Event
    July 11, 2022
    Report Date
    November 2, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DYB
    UDI-DI
    00733132628360
    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

    H3: CODE "OTHER" WAS SELECTED AS THE MEDICAL DEVICE WAS DISCARDED AT FACILITY. RETURN NOT POSSIBLE.H6: CODE 1802 ¿ THE CESSATION OF LIFE.H6: CODE 4001 ¿ PROBLEM RELATED TO THE INTERACTION BETWEEN THE PATIENT AND THE DEVICE.H6: CODE 4742 ¿ A COMPONENT WHOSE FUNCTION IS TO FACILITATE THE INSERTION OF A PARTICULAR DEVICE.H6: CODE 4111 ¿ THE INVESTIGATION INVOLVED COMMUNICATION/INTERVIEWS (EITHER INTERPERSONAL OR THROUGH TECHNICAL MEANS, E.G. PHONE, E-MAIL) WITH PERSONS CLOSE TO THE ADVERSE EVENT, E.G. HEALTHCARE PROFESSIONALS (DOCTORS, NURSES ETC.), THE AFFECTED PATIENT(S) OR OTHER USERS INCLUDING, WHERE APPROPRIATE, RELATIVES OR OTHERS ENGAGED IN CARING FOR THE AFFECTED PATIENT.H6: CODE 4114 ¿ THE ACTUAL DEVICE INVOLVED IN THE ADVERSE EVENT WAS NOT RETURNED FOR TESTING DESPITE REQUESTS BY MANUFACTURER. MEDICAL DEVICE WAS DISCARDED AT FACILITY.H6: CODE 3233 ¿ INVESTIGATION IS ONGOING, AND RESULTS ARE NOT YET AVAILABLE. H6: CODE 11 ¿ A CONCLUSION HAS YET TO BE ESTABLISHED AS THE INVESTIGATION IS INCOMPLETE.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, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF A KINK OF PREVIOUS IMPLANTED FROZEN ELEPHANT TRUNK (FET) AND A THORACIC ANEURYSM ENLARGEMENT DUE TO A DISTAL TYPE I ENDOLEAK FROM FET. A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS DELIVERED USING A GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF2065) WHICH WAS INSERTED FROM THE LEFT FEMORAL ARTERY. HOWEVER, IT WAS NOT ABLE TO PASS THROUGH THE KINK OF FET. THE CATHETER OF GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS REMOVED ONCE TO CHANGE THE APPROACH TO PULL-THROUGH FROM THE BRACHIAL ARTERY. THEN, THE KINK OF FET WAS RELEASED AND DISTAL END OF FET MIGRATED INTO THE ANEURYSM. THE PULL-THROUGH WAS CREATED AND DISTAL END OF FET WAS RELOCATED TO THE DESCENDING AORTA USING WIRE TENSION. THEN, THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS IMPLANTED AS PLANNED. A FINAL ANGIOGRAPHY REVEALED NO ENDOLEAK. A SELECTIVE ANGIOGRAPHY WAS PERFORMED TO THE CELIAC ARTERY, THE SUPERIOR MESENTERIC ARTERY (SMA) AND THE RIGHT FEMORAL ARTERY TO CONFIRM WHETHER THE THROMBUS MIGRATION TO ABDOMINAL BRANCH VESSELS AND/OR LOWER LIMB OCCURRED DUE TO FET MIGRATION TO THE ANEURYSM. THE FLOW OF THE TRUNK OF THE CELIAC ARTERY AND THE SMA WAS WELL, BUT THE FLOW OF SOME BRANCH VESSELS OF THESE WAS NOT ABLE TO BE CONFIRMED. AND THE FLOW OF THE RIGHT FEMORAL ARTERY WAS ALSO NOT WELL. SO, THE PHYSICIAN DIAGNOSED THROMBUS MIGRATION. A THROMBECTOMY WAS PERFORMED TO THE CELIAC ARTERY AND THE SMA BY OPEN SURGERY AND A FOGARTY WAS PERFORMED TO THE RIGHT FEMORAL ARTERY. ON (B)(6) 2022, THE PATIENT DIED IN EARLY MORNING DUE TO THE THROMBUS FROM THE DESCENDING THORACIC AORTIC ANEURYSM WAS SCATTERED TO WHOLE BODY. THE PHYSICIAN SUGGESTED THAT THE THROMBUS SCATTERED DUE TO FET MIGRATION NOT AFTER CTAG IMPLANTATION. AND HE ALSO SAID THAT NO MATTER WHICH DEVICE HE USED, IF DEVICE DELIVERED VIA FA APPROACH, IT WOULD BE IMPOSSIBLE TO PASS THROUGH THE LINK OF FET WITHOUT ANY ISSUES. AND THE SHORT FET, LIKE THIS CASE, SHOULD HAVE NOT BEEN IMPLANTED AND THE SHORT FET MIGHT HAVE BECOME CAUSE OF KINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372805 GORE® DRYSEAL FLEX INTRODUCER SHEATH INTRODUCER, CATHETER DYB W. L. GORE & ASSOCIATES, INC. DSF2065 00733132628360

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Death