BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS

    MDR report key: 20468338 · Received October 17, 2024

    Report

    Report Number
    3007284313-2024-03520
    Event Type
    Malfunction
    Date Received
    October 17, 2024
    Date of Event
    September 18, 2024
    Report Date
    October 17, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132651016
    PMA / PMN Number
    P200030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: CODE "OTHER" WAS SELECTED AS THE MEDICAL DEVICE REMAINS IMPLANTED. RETURN NOT POSSIBLE. H6: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. H6: THE PRIMARY REPORTED DEVICE FAILURE MODE, WHERE THE PROXIMAL END OF DEVICE DID NOT FULLY EXPAND WHEN DEPLOYMENT WAS INITIATED, IS CONSISTENT WITH THE EVALUATION OF THE PROVIDED CLINICAL IMAGES. THE IMAGES SHOW A PARTIALLY EXPANDED DEVICE AT ONE TIME AND A FULLY EXPANDED DEVICE AT ANOTHER TIME. THIS IS CONSISTENT WITH THE INFORMATION REPORTING FULL EXPANSION ACHIEVED SUBSEQUENTLY THROUGH A POST-DEPLOYMENT BALLOON SEQUENCE; HOWEVER, THE STATE OF THE DELIVERY SYSTEM HANDLE AT THE TIME REPRESENTED BY EACH CLINICAL IMAGE IS NOT KNOWN SO A PRODUCT PERFORMANCE CONCLUSION CANNOT BE DRAWN ON THE BASIS OF THE IMAGES ALONE. THE CAUSE FOR THE INITIAL INABILITY TO ACHIEVE FULL EXPANSION AT THE PROXIMAL END OF THE DEVICE COULD NOT BE ESTABLISHED WITH THE AVAILABLE INFORMATION. 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) 2024 , THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES. THE TRUNK IPSILATERAL LEG WAS INITIALLY DEPLOYED JUST BELOW THE LEFT ADRENAL ARTERY, BUT THE PROXIMAL END OF THE DEVICE DID NOT FULLY DEPLOY. IT STILL DID NOT DEPLOY EVEN AFTER REMOVING THE CLEAR KNOB. EVENTUALLY, IT FULLY DEPLOYED AFTER A BALLOON TOUCH-UP WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE. PHYSICIAN¿S COMMENT: I ATTEMPTED TO REDEPLOY BY TURNING THE CONSTRAINING DIAL ANTI-CLOCKWISE, BUT IT DID NOT WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1249816 GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132651016

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Male