BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 20130920 · Received September 3, 2024

    Report

    Report Number
    3007284313-2024-03466
    Event Type
    Death
    Date Received
    September 3, 2024
    Date of Event
    August 7, 2024
    Report Date
    September 30, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132619078
    PMA / PMN Number
    P020004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: CODE C19-A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET ALL PRE-RELEASE MANUFACTURING SPECIFICATIONS. AS THE DEVICE WAS NOT ACCESSIBLE, THE PRODUCT HISTORY REVIEW (PHR) REVIEW WAS THE EXTEND OF THE INVESTIGATION. NO DEVICE PROBLEM WAS FOUND PER REVIEW OF THESE RECORDS. H6: CODE C20: THE DEVICE REMAINS IMPLANTED AND, THEREFORE, WAS NOT AVAILABLE FOR DIRECT ANALYSIS BY GORE. IN ADDITION, THE DELIVERY CATHETER WAS DISCARDED. 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

    UPDATED SECTION G3/G4, B5, H6, AND H10. THE FOLLOWING PATIENT INFORMATION WAS PROVIDED: MEDICAL HISTORY: -SEVERE PAD, COPD, ACTIVE SMOKER. -5.5CM INFRARENAL AAA. -BILTERAL COMMON ILIAC ANEURYSMS ~5CM.

    Description of Event or Problem · 0

    ON (B)(6) 2024, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A ZONE-9-INFRARENAL ILIAC ANEURYSM UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS. DURING THE PROCEDURE AFTER THE FIRST STAGE WAS DEPLOYED, IT WAS OBSERVED THAT THE TOP OF THE DEVICE WAS NOT FULLY OPENED AND THE SECTION BY THE CONTRALATERAL GATE WAS ALSO CONSTRAINED DUE TO PATIENT ANATOMY. THE PHYSICIAN CONSTRAINED AND REPOSITIONED THE DEVICE, HOWEVER THE PROXIMAL END OF DEVICE STILL WOULD NOT OPEN UP ONCE THE GRAY DIAL WAS TURNED. THE PHYSICIAN COULD NOT PLACE A WIRE THROUGH THE TOP OF THE GRAFT, AND SO PHYSICIAN CAME UP THROUGH THE IPSILATERAL SIDE WITH A WIRE. AN ATLAS BALLOON WAS THEN USED TO OPEN UP PROXIMAL END OF THE DEVICE. SOME TIME AFTER (30MINS-1HR), THE PHYSICIAN THEN PLACED A WIRE THROUGH THE CONTRALATERAL GATE SECTION AND WAS ABLE TO USE A SMALL BALLOON TO OPEN UP THE SECTION. THE DEVICE WAS SUCCESSFULLY IMPLANTED WITH NO FURTHER ISSUES. PATIENT TOLERATED THE PROCEDURE. THE CAUSE OF THIS ISSUE REMAINS UNKNOWN. THE DELIVERY CATHETER WAS DISCARDED. NO FURTHER PATIENT INFORMATION OR IMAGES ARE AVAILABLE. ON 8/23/2024, IT WAS LATER REPORTED, PATIENT EXPIRED. DATE OF DEATH AND CAUSE REMAINS UNKNOWN. FURTHER INFORMATION HAS BEEN REQUESTED. ONCE ADDITIONAL INFORMATION HAD BEEN OBTAINED, THIS CASE WILL BE UPDATED ACCORDINGLY.

    Description of Event or Problem · 0

    ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2024. PHYSICIAN ATTRIBUTES PATIENT DEATH TO PROLONGED SURGERY LEADING TO BILATERAL LOWER EXTREMITY (LEFT WORSE THAN RIGHT) COMPARTMENT SYNDROME. THE ADDITIONAL STEPS TAKEN IN THIS CASE, ADDED AN EXTRA 1+ HOUR TO THE OR TIME WITH ESSENTIALLY A PARTIAL AORTIC OCCLUSION. IT WAS ALSO REPORTED DUE TO KINKED CONTRALATERAL GATE AND PARTIALLY CONSTRAINED MAIN BODY, THE LEFT LEG WAS ISCHEMIC FOR A PROLONGED TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712271 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132619078

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death| O