BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 17399201 · Received July 26, 2023

    Report

    Report Number
    3013164176-2023-01767
    Event Type
    Injury
    Date Received
    July 26, 2023
    Date of Event
    June 29, 2023
    Report Date
    July 26, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132618712
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.10. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: ATORVASTATIN CALCIUM 80 MG ORAL TABLET, METFORMIN HCL 1000 MG ORAL TABLE, VITAMIN D (ERGOCALCIFEROL) 1.25 MG (50000 UT) ORAL CAPSULE, ONETOUCH ULTRA IN VITRO STRIP, OZEMPIC (0.25 OR 0.5 MG/DOSE) 2 MG/3ML SUBCUTANEOUS SOLUTION PEN-INJECTOR, LEVEMIR FLEXPEN 100 UNIT/ML SUBCUTANEOUS SOLUTION PEN-INJECTOR, TIZANIDINE HCL 4 MG ORAL CAPSULE 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. 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 OR ADDITIONAL INTRAOPERATIVE PROCEDURE TIME INCLUDE, BUT ARE NOT LIMITED TO, ENDOPROSTHESIS OCCLUSION AND OCCLUSION OF THE DEVICE OR NATIVE VESSEL. 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

    ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A 4CM ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS REPORTED THAT THE PATIENT'S AORTIC BIFURCATION WAS NARROW AND, AFTER BALLOON DILATION OF THE PATIENT'S LEFT LIMB, COMPRESSION OF THE RIGHT LIMB OCCURRED DUE TO THE NARROW BIFURCATION. REPORTEDLY, THE CONTRALATERAL LEG COMPONENT WAS ONLY COMPRESSED NEAR THE AORTIC BIFURCATION WHERE THE BALLOONING OF THE RIGHT LIMB HAD OCCURRED. IT WAS REPORTED THAT, ON THE MORNING OF (B)(6) 2023, THE PATIENT COMPLAINED OF LEG PAIN AND THE CONTRALATERAL LEG COMPONENT WAS FOUND TO BE THROMBOSED UP TO THE AORTIC BIFURCATION WHERE COMPRESSION HAD OCCURRED. THE LIMB WAS REPORTED AS FULLY OCCLUDED. IT WAS NOTED THAT THE TRUNK AND CONTRALATERAL LEG GATE OF THE TRUNK-IPSILATERAL LEG COMPONENT WERE FREE FROM THROMBUS, OCCLUSION, AND/OR COMPRESSION. THE PHYSICIAN PERFORMED A FEM-FEM BYPASS ON THE SAME DAY. THE REINTERVENTION WAS REPORTED AS SUCCESSFUL. THERE WERE NO FURTHER REPORTED ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636942 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132618712

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention SEE H10 FOR LIST OF MEDICATIONS