BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS

    MDR report key: 18384202 · Received December 22, 2023

    Report

    Report Number
    3007284313-2023-02974
    Event Type
    Injury
    Date Received
    December 22, 2023
    Date of Event
    November 29, 2023
    Report Date
    February 9, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132651054
    PMA / PMN Number
    P200030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6.: CODE D12: ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO, ENDOLEAK. ADDITIONALLY, THE SAFETY AND EFFECTIVENESS OF THE GORE® EXCLUDER® AAA ENDOPROSTHESIS HAVE NOT BEEN EVALUATED IN THE FOLLOWING PATIENT POPULATIONS: PATIENTS WITH LESS THAN 15 MM IN LENGTH OR > 60° ANGULATION OF THE PROXIMAL AORTIC NECK. ADDITIONAL CONSIDERATIONS FOR PATIENT SELECTION INCLUDE BUT ARE NOT LIMITED TO: PATIENT¿S ANATOMICAL SUITABILITY FOR ENDOVASCULAR REPAIR. ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), POTENTIAL DEVICE OR PROCEDURE-RELATED ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO, ENDOLEAK AND DEVICE/NATIVE VESSEL OBSTRUCTION AND, OR OCCLUSION. IMPROPER COMPONENT PLACEMENT, AND COMPONENT MIGRATION.

    Additional Manufacturer Narrative · 0

    G.3: PMA/510(K)NUMBER P020004 CORRECTED TO P200030.

    Additional Manufacturer Narrative · 0

    H6: CODE C19: A REVIEW OF MANUFACTURING RECORDS VERIFIED THAT THE LOT INVOLVED IN THIS COMPLAINT MET ALL PRE-RELEASE SPECIFICATIONS. H6: CODE B20: DEVICE REMAINS IMPLANTED AND THEREFORE NOT AVAILABLE FOR DIRECT ANALYSIS. H6: CODE A27: USED TO CAPTURE LEFT RENAL ARTERY WAS COVERED ABOUT 3MM BY THE TRUNK - IPSILATERAL LEG ENDOPROSTHESIS. 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.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2023, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF A RUPTURED ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. ANGIOGRAPHY PERFORMED AFTER ALL STENT GRAFTS IMPLANTATION REVEALED THAT THE LEFT RENAL ARTERY WAS COVERED ABOUT 3MM BY THE TRUNK - IPSILATERAL LEG ENDOPROSTHESIS. ALTHOUGH THERE WAS NO BLOOD FLOW DELAY, A BARE METAL STENT WAS IMPLANTED IN THE LEFT RENAL ARTERY TO PREVENT OCCLUSION. FINAL ANGIOGRAPHY SHOWED A PROXIMAL TYPE I ENDOLEAK, BUT THE ENDOLEAK WAS NOT TREATED AND DECIDED TO BE MONITORED. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN REPORTEDLY STATED AS FOLLOWS: BECAUSE THE PROXIMAL NECK WAS POOR, I WANTED TO IMPLANT THE TRUNK - IPSILATERAL LEG ENDOPROSTHESIS WITH THE POSITION WHERE THE FIRST STENT LINE POSITIONED JUST BELOW THE LEFT RENAL ARTERY. THEREFORE, IT WAS EXPECTABLE THAT THE LEFT RENAL ARTERY COULD BE COVERED BY THE TRUNK - IPSILATERAL LEG ENDOPROSTHESIS A LITTLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2296801 GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132651054

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Other