BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS

    MDR report key: 21529211 · Received March 5, 2025

    Report

    Report Number
    3007284313-2025-03808
    Event Type
    Malfunction
    Date Received
    March 5, 2025
    Date of Event
    February 14, 2025
    Report Date
    June 3, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132651054
    PMA / PMN Number
    P200030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION PERFORMED BY ENGINEERING SHOWED THE FOLLOWING: ¿ THE DELIVERY SYSTEM CATHETER WAS RETURNED WITHOUT THE LEADING TIP. ¿ ENGINEERING IDENTIFIED MATERIAL REFLOW, CONSISTENT WITH A BOND BETWEEN THE CATHETER AND INNER MEMBER. BASED ON THE FINDINGS FROM THE EVALUATION, THE CONDITION OF THE RETURNED DEVICE IS CONSISTENT WITH THE PHYSICIAN¿S OBSERVATION THAT ¿WHEN REMOVING THE DELIVERY SYSTEM AND PULLED BACK THROUGH THE SHEATH THE TECH GOT IT CAUGHT ON THE SHEATH; OR PULLED TO HARD AND THE LEADING OLIVE BECAME DETACHED¿. THE RETURNED DEVICE HAS EVIDENCE OF REFLOWED MATERIAL INDICATIVE OF A LEADING TIP BOND. NO MANUFACTURING DEFICIENCY WAS IDENTIFIED, AS A RESULT NO CAPA REQUEST IS REQUIRED PER ENGINEERING EVALUATION TASK PROCEDURE. THIS TYPE OF EVENT WILL CONTINUE TO BE MONITORED PER PROCEDURE FOR EVENT TRENDING, ANALYSIS, AND REVIEW.

    Description of Event or Problem · 0

    ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A ZONE 9 INFRARENAL ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES FEATURING C3® DEPLOYMENT SYSTEM (CXT282412/(B)(6). IT WAS REPORTED THAT THE DEVICE WAS DEPLOYED WITHOUT INCIDENT, BUT WHEN REMOVING THE DELIVERY SYSTEM AND PULLED BACK THROUGH THE SHEATH THE TECH GOT IT CAUGHT ON THE SHEATH; OR PULLED TO HARD AND THE LEADING OLIVE BECAME DETACHED. THE LEADING OLIVE WAS RETRIEVED FROM THE PATIENT WITHOUT ISSUE OR INJURY. THE PATIENT TOLERATED THE PROCEDURE WITH GOOD RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2630392 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 85 YR Male