BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 20425411 · Received October 11, 2024

    Report

    Report Number
    3007284313-2024-03517
    Event Type
    Death
    Date Received
    October 11, 2024
    Date of Event
    September 25, 2024
    Report Date
    October 11, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B2: THE EXACT DATE OF THE PATIENT DEATH IS UNKNOWN ((B)(6) 2024), THEREFORE (B)(6) 2024 IS USED AS "DATE OF PATIENT DEATH". H3: CODE "OTHER" WAS SELECTED AS THE MEDICAL DEVICES NOT AVAILABLE FOR RETURN. H6: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. H6: CODE D12: ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: ENDOLEAK, BLEEDING COMPLICATIONS, DEATH. 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

    THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT VOMITED UP BLOOD DUE TO AN AORTIC DUODENAL FISTULA AND AN ABDOMINAL AORTIC ANEURYSM RUPTURE AND TRANSFERRED URGENTLY TO THE HOSPITAL. THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF THE AORTIC DUODENAL FISTULA AND THE ABDOMINAL AORTIC ANEURYSM RUPTURE USING GORE® EXCLUDER® AAA ENDOPROSTHESES. DURING THE PROCEDURE, A TYPE IIIA ENDOLEAK WAS SUSPECTED BETWEEN A TRUNK IPSILATERAL LEG ENDOPROSTHESIS AND A CONTRALATERAL LEG ENDOPROSTHESIS. AN ILIAC EXTENDER ENDOPROSTHESIS WAS IMPLANTED TO RELINE THE SITE WHICH WAS SUSPECTED THE TYPE IIIA ENDOLEAK. THE PROCEDURE WAS CONCLUDED WITH THE LEAK REMAINED, BUT IT WAS UNKNOWN THE TYPE OF THIS LEAK (POSSIBLE TYPE IIIA ENDOLEAK OR TYPE II ENDOLEAK). THE PATIENT DIED AFTER THE PROCEDURE WITHOUT REINTERVENTION (THE PATIENT DIED SAME DAY OF THE PROCEDURE OR THE FOLLOWING DAY OF THE PROCEDURE). THE PHYSICIAN STATED THAT THE LEAK WAS CONFIRMED BUT IT WAS UNKNOWN THE TYPE OF THE ENDOLEAK (TYPE IIIA ENDOLEAK OR TYPE II ENDOLEAK?). THE PHYSICIAN STATED THAT THE CAUSE OF THE DEATH WAS BLEEDING FROM THE RUPTURE. THE PHYSICIAN STATED THAT THE PATIENT PRE-EXISTING CONDITION HAD BEEN POOR. IT WAS REPORTED THE PATIENT REQUIRED A TRANSFUSION CONTINUOUSLY AND THE TRANSFUSION WAS CONTINUED AFTER THE PROCEDURE WHEN THE PATIENT RETURNED TO ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300174 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Death