BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 21877357 · Received April 21, 2025

    Report

    Report Number
    3013164176-2025-02487
    Event Type
    Death
    Date Received
    April 21, 2025
    Date of Event
    March 26, 2025
    Report Date
    May 5, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132618613
    PMA / PMN Number
    P020004
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: CODE C19-A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOTS MET ALL PRE-RELEASE MANUFACTURING SPECIFICATIONS. AS THE DEVICES WERE NOT ACCESSIBLE, THE PRODUCT HISTORY REVIEW (PHR) REVIEW WAS THE EXTEND OF THE INVESTIGATION. NO DEVICE PROBLEM WAS FOUND PER REVIEW OF THESE RECORDS. UPDATED SECTION G3/G4, AND H6-TYPE OF INVESTIGATION AND INVESTIGATION FINDINGS.

    Additional Manufacturer Narrative · 0

    AS IT IS UNKNOWN WHICH DEVICE IS DIRECTLY IMPLICATED IN THIS PARAPLEGIA EVENT, THE FOLLOWING DEVICES WILL ALSO BE INCLUDED IN THIS REPORT: CATALOG#PLL161207/SERIAL# (B)(6)/ UDI(B)(4). CATALOG #PLL161007/ SERIAL # (B)(6)/ UDI # (B)(4). H6: CODE B20 ¿ THE DEVICE REMAINS IMPLANTED AND, THEREFORE, WAS NOT AVAILABLE FOR DIRECT ANALYSIS BY GORE. H6: CODE C21 - RESULTS PENDING COMPLETION OF PRODUCT HISTORY REVIEW. IT SHOULD BE NOTED THAT, PER THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO, VASCULAR SPASM OR VASCULAR TRAUMA (E.G., AORTA DISSECTION, AORTA DAMAGE, ILIO-FEMORAL VESSEL DISSECTION, BLEEDING, RUPTURE, DEATH) AND 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

    ON (B)(6) 2025, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A ZONE 9 ANEURYSM, UTILIZING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (CXT321414) AND GORE® EXCLUDER® AAA ENDOPROSTHESIS (PLL161207, PLL161007, AND PLC121000). DURING THE PROCEDURE, ALL DEVICES WERE IMPLANTED WITH NO ISSUES. SOON AFTER THE PATIENT'S BLOOD PRESSURE SEEMED TO DROP, BILATERAL ILIAC RUPTURE WAS OBSERVED, AND PATIENT EXPIRED. IT WAS ALSO REPORTED PHYSICIAN DOES NOT KNOW WHAT CAUSED THIS ISSUE. PHYSICIAN ALSO REPORTED PATIENT HAD A VERY THIN ARTERY. NO FURTHER PATIENT OR CASE INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016283 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132618613

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Death