BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 17886798 · Received October 6, 2023

    Report

    Report Number
    3007284313-2023-02807
    Event Type
    Injury
    Date Received
    October 6, 2023
    Date of Event
    September 1, 2023
    Report Date
    November 10, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION FINDINGS CODE C19: THE DEVICE REMAINS IMPLANTED AND IS NOT AVAILABLE FOR ANALYSIS. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. H.6. INVESTIGATION CONCLUSIONS CODE D12: ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), USERS ARE MADE AWARE OF THE RISKS ASSOCIATED WITH TYPE II ENDOLEAKS AND ARE INSTRUCTED TO CONSIDER THE RISKS AND BENEFITS DISCUSSED IN THE IFU FOR EACH PATIENT BEFORE USING THE DEVICES. SPECIFICALLY, THE IFU WARNS THAT ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO ENDOLEAK.

    Additional Manufacturer Narrative · 0

    THE REINTERVENTION OF JUNE 28, 2019 WAS REPORTED TO THE FDA IN MANUFACTURER REPORT 2017233-2019-00548. H.6. INVESTIGATION FINDINGS CODE C21: RESULTS PENDING PRODUCT HISTORY REVIEW. ADDITIONAL GORE® EXCLUDER® DEVICES THAT ARE CAPTURED ON THIS REPORT DUE TO BEING EXPLANTED ARE: #1 SN:(B)(6). UDI:(B)(4). CATALOG: PLC271000J. #2 SN: (B)(6). UDI: (B)(4). CATALOG: PLC201400J. #3 SN: (B)(6). UDI: (B)(4). CATALOG: PXA280300J. 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. INVESTIGATION FINDINGS CODE C19: THE DEVICE WAS DISCARDED AT THE TREATING FACILITY AND WAS THEREFORE NOT AVAILABLE FOR ANALYSIS. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. IN ADDITIONAL MANUFACTURER NARRATIVE - DELETE THE PREVIOUS STATEMENT REGARDING CODE C19 AND REPLACE WITH THE NEW STATEMENT.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2015, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2019, A REINTERVENTION WAS PERFORMED FOR TYPE IA ENDOLEAK, TYPE II ENDOLEAK AND ANEURYSM ENLARGEMENT. AN AORTIC EXTENDER COMPONENT WAS ADDITIONALLY IMPLANTED AND LUMBAR ARTERIES. (PREVIOUSLY REPORTED TO THE FDA). ON (B)(6) 2023, ANOTHER REINTERVENTION (OPEN CONVERSION) WAS PERFORMED. THE PROXIMAL PART OF THE IMPLANTED DEVICES WAS CUT AND THE DEVICES WERE EXPLANTED FROM THE PATIENT. THE ABDOMINAL AORTA WAS REPLACED WITH A Y-SHAPE VASCULAR GRAFT. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: BASED ON FINDINGS OF THE OPEN CONVERSION, THE CAUSE OF ANEURYSM ENLARGEMENT WAS JUDGED AS TYPE II ENDOLEAK ORIGINATING FROM THE INFERIOR MESENTERIC ARTERY AND L2 ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201756 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention