BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 18775109 · Received February 25, 2024

    Report

    Report Number
    3007284313-2024-03067
    Event Type
    Malfunction
    Date Received
    February 25, 2024
    Date of Event
    January 29, 2024
    Report Date
    April 16, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO MANUFACTURER FOR ENGINEERING EVALUATION, WHICH SHOWED THE FOLLOWING: THE LOCKPIN IS INTACT AND SITS PROPERLY IN THE LEADING OLIVE. THE LEADING OLIVE SHOWS NO DAMAGE OR TORN TIP. NO DEFORMATIONS WERE NOTED. BASED ON THE FINDINGS OF THIS EVALUATION, THE PHYSICIAN¿S OBSERVATION THAT ¿PROXIMAL TIP SLIGHTLY TORN¿ COULD NOT BE CONFIRMED. THE LIKELY CAUSE FOR THE PHYSICIAN¿S OBSERVATION OF ¿PROXIMAL TIP SLIGHTLY TORN¿ COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION. THE PRODUCT EVALUATION RESULT DETERMINED THIS IS NOT A REPORTABLE COMPLAINT, AS THE ALLEGATION OF DEVICE DEFICIENCY OR MALFUNCTION (THE DAMAGE OF THE PROXIMAL TIP OF THE CATHETER) COULD NOT BE CONFIRMED. THEREFORE, MANUFACTURER REPORT # 3007284313-2024-03067 IS BEING RETRACTED. EMDR SECTION 6: CODES ARE UPDATED TO REFLECT THE RESULTS OF INVESTIGATION: MEDICAL DEVICE PROBLEM CODE (A0401 BREAK) IS REMOVED. INVESTIGATION FINDINGS UPDATED FROM C21 TO C19. INVESTIGATION CONCLUSION UPDATED FROM D16 TO D15.

    Additional Manufacturer Narrative · 0

    H6: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. 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 JANUARY 29, THIS PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. IT WAS REPORTED THAT THE PROXIMAL TIP OF A TRUNK - IPSILATERAL LEG ENDOPROSTHESIS WAS FOUND TO BE SLIGHTLY TORN DURING THE PROCEDURE. AN ALTERNATIVE TRUNK - IPSILATERAL LEG ENDOPROSTHESIS WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75370 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male