BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® EXCLUDER®AAA ENDOPROSTHESIS

    MDR report key: 21733601 · Received March 31, 2025

    Report

    Report Number
    3013164176-2025-02458
    Event Type
    Death
    Date Received
    March 31, 2025
    Date of Event
    March 9, 2025
    Report Date
    May 14, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132618439
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDED G3/G4, H1/H2. CORRECTION: 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 DEATH.

    Additional Manufacturer Narrative · 0

    AS IT IS UNKNOWN WHICH DEVICE(S) IS DIRECTLY IMPLICATED IN THIS DEATH EVENT, THE FOLLOWING DEVICE(S) WILL ALSO BE INCLUDED IN THIS REPORT: CATALOG #PLC181000/ SERIAL #(B)(6)/ UDI #(B)(4), CATALOG #PLC141200/ SERIAL #(B)(6)/ UDI #(B)(4). H6: CODE A26- USED TO CAPTURE INSUFFICIENT INFORMATION AVAILABLE TO DETERMINE IF GORE DEVICE CONTRIBUTED TO DEATH. H6: CODE E2401- USED TO CAPTURE INSUFFICIENT INFORMATION AVAILABLE TO DETERMINE IF ANY HEALTH EFFECT APPEARS TO HAVE OCCURRED. IT SHOULD BE NOTED THAT, PER THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE BUT ARE NOT LIMITED TO 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 HAVE NOT 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

    ADDED: G3/G4, H1/H2. CORRECTED: B3.

    Description of Event or Problem · 0

    THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM RUPTURE UTILIZING THE GORE® EXCLUDER® CONFORMABLE AAA IN ZONE 9. IT WAS REPORTED THAT THE PATIENT PRESENTED SYMPTOMATIC OF A RUPTURED ANEURYSM. HIS LEFT RENAL WAS INTENTIONALLY COVERED BECAUSE THE ANEURYSM EXTENDED TO THE LEFT RENAL. ALSO, TWO CONTRALATERAL LEGS WERE PLACED IN THE PATIENT. A FINAL ANGIOGRAM WAS PERFORMED THAT SHOWED NO EVIDENCE OF ENDOLEAK AND THE CONTAINMENT OF THE ANEURYSM SAC. THE RIGHT RENAL WAS FUNCTIONAL WITH NO ISSUES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE PATIENT'S RENAL FUNCTION DECLINED. THE PHYSICIAN PERFORMED AN OPEN RENAL REVASCULARIZATION WITH ENDOSCOPIC INTERVENTION. THE PHYSICIAN ALSO PERFORMED A LAPAROTOMY. AT SOME POINT DURING THESE PROCEDURES, AN AORTIC EXTENDER AND NON-GORE BARE METAL STENT WAS PLACED IN THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6), THE FSA WAS IN COMMUNICATION WITH THE PHYSICIAN. THE PHYSICIAN STATED THE PATIENT EXPIRED. THE EXACT EXPIRATION DATE IS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE. THE CAUSE OF THE REPORTED EVENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    954164 GORE® EXCLUDER®AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132618439

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Other| D ACETAMINOPHEN 500 MG, LACTULOSE 10 GM/15 ML ORAL