BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 21912701 · Received April 25, 2025

    Report

    Report Number
    3007284313-2025-03928
    Event Type
    Malfunction
    Date Received
    April 25, 2025
    Date of Event
    March 28, 2025
    Report Date
    April 25, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132622528
    PMA / PMN Number
    P020004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: CODE C19 - A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. ENGINEERING EVALUATION SUMMARY: · THE DEVICE EVALUATION SHOWED THE FOLLOWING: O ENGINEERING EXAMINED THE RETURNED COMPONENTS. ENGINEERING OBSERVED THAT THE FIRST DEPLOYMENT KNOB AND THE MAJORITY OF THE FIRST DEPLOYMENT LINE WAS REMOVED, BUT THE ENDOPROSTHESIS WAS STILL CONTAINED IN THE SLEEVE. O THE FIRST DEPLOYMENT LINE APPEARED TO BE BROKEN. O ENGINEERING EXAMINED THE SLEEVE UNDER MAGNIFICATION AND NONE OF THE STITCHES OF THE SLEEVE WERE UNLACED. AN UNINTENDED KNOT WAS OBSERVED. ENGINEERING WAS ABLE TO IDENTIFY THE OTHER END OF THE BROKEN LINE CAUGHT BY THIS UNINTENDED KNOT. · BASED ON THE FINDINGS FROM THIS EVALUATION, THE PHYSICIAN¿S OBSERVATION THAT ¿THE HANDLE PULLED ALL THE WAY BUT THE DEPLOYMENT STRING WAS STILL ATTACHED DEVICE DID NOT OPEN.¿ WAS CONFIRMED. THE LIKELY CAUSE FOR THE REPORTED OBSERVATION THAT ¿THE HANDLE PULLED ALL THE WAY BUT THE DEPLOYMENT STRING WAS STILL ATTACHED DEVICE DID NOT OPEN¿ WAS DETERMINED TO BE DUE TO A MANUFACTURING DEFICIENCY. 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 WAS REPORTED TO GORE: ON (B)(6), 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. REPORTEDLY, THE FIRST STAGE OF DEPLOYMENT WAS DONE WITH THE HANDLE PULLED ALL THE WAY BUT THE DEPLOYMENT STRING WAS STILL ATTACHED DEVICE DID NOT OPEN. PHYSICIAN REMOVED THE DEVICE FROM THE PATIENT AND USED A NEW DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO ISSUES WITHDRAWING THE DEVICE FROM THE PATIENT AND NO ANATOMICAL ISSUES OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390384 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132622528

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Other| L