BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 17272906 · Received July 6, 2023

    Report

    Report Number
    3007284313-2023-02603
    Event Type
    Death
    Date Received
    July 6, 2023
    Date of Event
    February 4, 2022
    Report Date
    November 23, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132610723
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6-B13: A REQUEST WAS EMAILED TO THE STUDY COORDINATOR TO CLARIFY THE CAUSE OF THE ISCHEMIA, THE RELATIONSHIP BETWEEN THE DEVICE/PROCEDURE AND THE ISCHEMIA, AND IF PATIENT IMAGING IS AVAILABLE. THE ANSWER IS PENDING. H6-B14: THE MANUFACTURING RECORDS ARE BEING REVIEWED. H6-B20 AND H3-OTHER: THE DEVICE REMAINS IMPLANTED IN THE PATIENT. THEREFORE A DEVICE EVALUATION COULD NOT 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

    D10 CONCOMITANT MEDICAL PRODUCTS: GORE® EXCLUDER® AAA ENDOPROSTHESIS (SERIAL NUMBER (B)(6), CATALOG PXC181200). GORE® EXCLUDER® AAA ENDOPROSTHESIS (SERIAL NUMBER (B)(6), CATALOG PXC181000). CAUSE INVESTIGATION AND CONCLUSION: THE INCIDENT INFORMATION WAS RECEIVED FROM A PROSPECTIVE STUDY. THE DATABASE ENTRIES WERE REVIEWED AND THE PROVIDED INFORMATION WAS CAPTURED IN SECTIONS A THROUGH E. REQUEST WAS EMAILED TO THE STUDY COORDINATOR TO CLARIFY THE CAUSE OF THE ISCHEMIA, THE RELATIONSHIP BETWEEN THE DEVICE/PROCEDURE AND THE ISCHEMIA, AND IF PATIENT IMAGING IS AVAILABLE. THE REQUESTS REMAINED UNANSWERED. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET PRE-RELEASE MANUFACTURING SPECIFICATIONS. NEITHER IMAGES ENABLING DIRECT ASSESSMENT OF PRODUCT PERFORMANCE NOR THE PRODUCT ITSELF, WHICH REMAINS IMPLANTED, WERE RETURNED FOR EVALUATION. BASED ON THE INCIDENT DESCRIPTION AND THE SUBSEQUENT INVESTIGATION, NO FURTHER INFORMATION WAS PROVIDED TO GORE, WE ARE UNABLE TO DETERMINE THE CAUSE OF THIS INCIDENT AND ASSIGN A ROOT CAUSE TO THE REPORTED ISCHEMIC COLITIS. THE PHYSICIAN STATED THAT THE DEVICE OR PROCEDURE CONTRIBUTED TO THE CONDITION. NO FURTHER INFORMATION WAS PROVIDE TO GORE. IT REMAINS UNCLEAR TO WHAT EXTENT THE PRODUCT OR PROCEDURE CONTRIBUTED TO THE REPORTED ISCHEMIC COLITIS. THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), FOR THE APPROPRIATE REGION AND TIME-PERIOD, WAS REVIEWED WITH RESPECT TO THE COMPLAINT DETAIL. THE IFU STATES THE FOLLOWING: POTENTIAL DEVICE OR PROCEDURE-RELATED ADVERSE EVENTS ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION OR ADDITIONAL INTRAOPERATIVE PROCEDURE TIME INCLUDE, BUT ARE NOT LIMITED TO: ANEURYSM ENLARGEMENT; BOWEL COMPLICATIONS (E.G., ILEUS, TRANSIENT ISCHEMIA, INFARCTION, NECROSIS).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2011, A PATIENT PRESENTING WITH AN ABDOMINAL AORTIC ANEURYSM WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2014, COMPUTED TOMOGRAPHY (CT) IMAGING SHOWED A MAXIMUM AORTIC ANEURYSM DIAMETER OF 72.2 MM. ON (B)(6) 2022, THE LAST DATE WHEN IMAGING WAS AVAILABLE, CT IMAGING SHOWED A MAXIMUM AORTIC ANEURYSM DIAMETER OF 103 MM. ON (B)(6) 2022, THE PATIENT PRESENTED WITH ISCHEMIC COLITIS. THE PHYSICIAN STATED THAT THE DEVICE OR PROCEDURE CONTRIBUTED TO THE CONDITION. NO TREATMENT WAS DOCUMENTED. THE PATIENT DIED DUE TO THE SAME CONDITION ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640650 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. RMT281416 00733132610723

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male Death| H