BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 16736948 · Received April 13, 2023

    Report

    Report Number
    2953161-2023-01172
    Event Type
    Injury
    Date Received
    April 13, 2023
    Date of Event
    January 1, 2013
    Report Date
    April 13, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132609925
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT MEDICAL HISTORY INCLUDES BUT IS NOT LIMITED TO: HYPERLIPIDEMIA, HYPERTENSION, SEEP APNEA, AORTIC STENOSIS, COVID-19. CONCOMITANT MEDICAL PRODUCT(S): PATIENT MEDICATIONS INCLUDE BUT ARE NOT LIMITED TO: VANCOMYCIN, CARDIZEM, METROPROLOL TARTRATE, MONODOX, LIPITOR, ZETIA, ELIQUIS. ADVERSE EVENT PROBLEM: CODE D1101: ACCORDING TO THE INSTRUCTIONS FOR USE(IFU), THE SAFETY AND EFFECTIVENESS OF THE GORE® EXCLUDER® AAA ENDOPROSTHESIS HAS NOT BEEN EVALUATED IN THE FOLLOWING PATIENT POPULATIONS: REVISION OF PREVIOUSLY PLACED STENT GRAFTS. 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) 2008, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WHICH HAD BEEN PREVIOUSLY (DATE UNKNOWN) TREATED WITH ENDOLOGIX DEVICES. GORE® EXCLUDER® AAA ENDOPROSTHESES WERE IMPLANTED TO RELINE THE ENDOLOGIX DEVICES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, THE PATIENT UNDERWENT REINTERVENTION FOR AN ENLARGING ANEURYSM AND A TYPE III ENDOLEAK ASSOCIATED WITH A HOLE IN A DACRON GRAFT AND GORE® EXCLUDER® AAA CONTRALATERAL LIMB WAS IMPLANTED TO RELINE THE DACRON GRAFT. THE GORE ASSOCIATE SUPPORTING THIS PROCEDURE WAS MADE AWARE AT THIS TIME, THAT THE GORE DEVICES HAD BEEN EXPLANTED AND A DACRON GRAFT HAD BEEN SEWED IN ON AN UNKNOWN DATE AND YEAR BUT THOUGHT TO HAVE BEEN TEN OR SO YEARS AGO. NO ADDITIONAL INFORMATION REGARDING THE EXPLANT WAS KNOWN. THE PATIENT TOLERATED THE PROCEDURE. THE DATE OF EVENT (EXPLANT) IS ESTIMATED TO BE ON OR ABOUT (B)(6) 2013, THE REINTERVENTION ON (B)(6) 2023 IS NOT RELEVANT AS THERE WERE NO GORE DEVICES ASSOCIATED WITH THE TYPE III ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1245048 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. PXC121200 00733132609925

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Male Other| H| R