BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 20554398 · Received October 29, 2024

    Report

    Report Number
    3007284313-2024-03545
    Event Type
    Death
    Date Received
    October 29, 2024
    Date of Event
    September 30, 2024
    Report Date
    March 28, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132622375
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION CONCLUSIONS: CODE D1001 ADDED. H.6. INVESTIGATION CONCLUSIONS: CODE D12 REMAINS UNCHANGED. H.6. INVESTIGATION CONCLUSIONS: CODE D15 REMAINS UNCHANGED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL DEVICES INCLUDED ON THIS REPORT ARE AS FOLLOWS: CATALOG #PLC121000/ SERIAL # (B)(6) / UDI # (B)(4) AS A COMPONENT OF THE SAME SYSTEM. A.4. PATIENT WEIGHT: THIS INFORMATION REMAINS UNAVAILABLE TO GORE. B.7. OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS: THIS INFORMATION REMAINS UNAVAILABLE TO GORE D.10. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: THIS INFORMATION REMAINS UNAVAILABLE TO GORE. H.6. TYPE OF INVESTIGATION: CODE B15 - IMAGES WERE PROVIDED, AND AN IMAGING EVALUATION WILL BE PERFORMED. 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.

    Additional Manufacturer Narrative · 0

    H.6. HEALTH EFFECT - CLINICAL CODE: CODE E1002 ADDED H.6. INVESTIGATION FINDINGS FOR ANALYSIS OF PRODUCTION RECORDS: CODE C21 UPDATED TO CODE C19 H.6. INVESTIGATION FINDINGS FOR ANALYSIS OF PRODUCTION RECORDS: CODE C19 - THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THE LOTS INVOLVED IN THIS EVENT MET ALL PRE-RELEASE SPECIFICATIONS. THE REVIEW OF THE STERILIZATION PAPERWORK VERIFIED THAT THE LOTS INVOLVED IN THIS EVENT MET ALL PRE-RELEASE SPECIFICATIONS. H.6. INVESTIGATION FINDINGS FOR IMAGING EVALUATION: CODE C21 UPDATED TO CODE C19 H.6. INVESTIGATION FINDINGS FOR IMAGING EVALUATION: CODE C19 - THE IMAGING EVALUATION WAS PERFORMED BY A CLINICAL IMAGING SPECIALIST. TWO TIME-POINTS WERE AVAILABLE FOR EVALUATION: PRE-IMPLANTATION CTA DATED (B)(6) 2024, AND POST-IMPLANTATION CTA DATED (B)(6) 2024. THE PRE-IMPLANTATION CTA SHOWED PRESENCE OF SURGICAL HARDWARE IN THE PATIENT¿S SPINE. THE PRESENCE OF THIS HARDWARE CAUSED STREAK ARTIFACT ON THE IMAGING. POST-IMPLANTATION CTA SHOWED THAT THE LENGTH FROM THE LEFT RENAL ARTERY (LRA) TO THE PROXIMAL CIRCUMFERENTIAL DEVICE APPEARED TO BE 14.6MM, BY CENTERLINE. THE AORTIC DIAMETER JUST DISTAL TO THE LRA APPEARED TO BE 17.6MM. THE AORTIC DIAMETER 15MM DISTAL TO THE LRA APPEARED TO BE 25.4MM. CONTRAST WAS SEEN OUTSIDE THE PROXIMAL END OF THE DEVICE, THEREBY CONFIRMING A PROXIMAL TYPE I ENDOLEAK. AXIAL IMAGE SHOWED CONTRAST IN THE COMMON ILIAC ARTERY ANEURYSM SACS, THEREBY CONFIRMING DISTAL TYPE I ENDOLEAKS BILATERALLY. THERE WAS LACK OF CIRCUMFERENTIAL DISTAL DEVICE APPOSITION IN BOTH COMMON ILIAC ARTERIES. H.6. INVESTIGATION CONCLUSIONS: CODE D15 - THERE IS INSUFFICIENT INFORMATION AVAILABLE FOR GORE TO REASONABLY DRAW CONCLUSIONS RELATED TO ASPECTS OF THE EVENT, THEREFORE CONCLUSION CODE ¿D15: CAUSE NOT ESTABLISHED¿ IS BEING USED. INSUFFICIENT INFORMATION MAY INCLUDE LIMITED OR MISSING RELEVANT MEDICAL RECORDS, INVOLVEMENT OF MULTIPLE IMPLANTED DEVICES (INCLUDING NON-GORE DEVICES) IN THE FIELD OF TREATMENT, PATIENT NON-COMPLIANCE, AND/OR A GENERAL LACK OF AVAILABLE DETAIL OR SPECIFICITY RELATED TO AN ADVERSE EVENT AND/OR DEVICE. H.6. INVESTIGATION CONCLUSIONS: CODE D12 ADDED ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESES INSTRUCTIONS FOR USE, POTENTIAL DEVICE OR PROCEDURE RELATED ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION OR ADDITIONAL INTRAOPERATIVE PROCEDURE TIME INCLUDE, BUT ARE NOT LIMITED TO, ENDOLEAK, INFECTION (E.G., ANEURYSM, DEVICE, OR ACCESS SITES), SURGICAL CUT DOWN, BYPASS OR CONVERSION, AND DEATH. ADDITIONALLY, THE SAFETY AND EFFECTIVENESS OF THE GORE® EXCLUDER® AAA ENDOPROSTHESIS HAVE NOT BEEN EVALUATED IN PATIENT POPULATIONS INCLUDING, BUT NOT LIMITED TO, RUPTURED ANEURYSMS.

    Description of Event or Problem · 0

    ON (B)(6) 2024, THE PATIENT UNDERWENT EMERGENT ENDOVASCULAR TREATMENT OF A RUPTURED ABDOMINAL AORTIC ANEURYSM (AAA) USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2024, THE PATIENT PRESENTED BACK TO THE ED WITH ABDOMINAL PAIN. BLOOD WORK SHOWED AN ELEVATED WHITE COUNT. ADDITIONALLY, CT IMAGING OF THE PATIENT'S ABDOMEN WAS PERFORMED WHICH SHOWED A PROXIMAL TYPE I AND BILATERAL DISTAL TYPE I ENDOLEAKS. THE PHYSICIAN REPORTED THAT THE ENDOLEAKS WERE SUSPECTED TO BE DUE TO INFLAMMATION IN THE AORTA. A PLA230300 GORE® EXCLUDER® AAA AORTIC EXTENDER COMPONENT AND TWO GORE® EXCLUDER® AAA ILIAC EXTENDER COMPONENTS (PLL161207 AND PLL161407) WERE IMPLANTED TO RESEAL THE ANEURYSM AND STABILIZE THE PATIENT WHO WAS REPORTEDLY TOO UNSTABLE TO UNDERGO DEVICE EXPLANT AT THAT TIME. ON (B)(6) 2024, THE PATIENT WAS TAKEN TO THE OR AND THE GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICE SYSTEM WAS EXPLANTED DUE TO SYSTEMIC INFECTION. THE SOURCE OF THE INFECTION WAS UNKNOWN. IT IS UNKNOWN IF THE PATIENT HAD AN ACTIVE INFECTION AT THE TIME OF DEVICE IMPLANT TO TREAT THE PRE-EXISTING RUPTURED AAA. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT EXPIRED ON AN UNKNOWN DATE AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318884 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132622375

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Death| R