BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 15840757 · Received November 21, 2022

    Report

    Report Number
    3013164176-2022-01548
    Event Type
    Malfunction
    Date Received
    November 21, 2022
    Date of Event
    October 25, 2022
    Report Date
    January 18, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132618668
    PMA / PMN Number
    P020004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED CODE FROM D16 TO D15 UNDER INVESTIGATION CONCLUSIONS. THE DEVICE EVALUATION SHOWED THE FOLLOWING: THE LEADING END OF THE CATHETER (POLYIMIDE GUIDEWIRE LUMEN) HAD SEPARATED FROM THE CATHETER BODY AT THE TRAILING OLIVE. THE POLYIMIDE GUIDEWIRE LUMEN HAD PULLED OUT OF THE TRAILING OLIVE BOND. THERE WAS EVIDENCE OF GOLD COATING COLOR MATERIAL FROM THE POLYIMIDE GUIDEWIRE LUMEN OBSERVED INSIDE OF THE TRAILING OLIVE INDICATING THAT THE OLIVE HAD BEEN BONDED TO THE POLYIMIDE GUIDEWIRE LUMEN. THE END OF THE GUIDEWIRE LUMEN WAS EXAMINED FOR EVIDENCE OF A TENSILE BREAK. THE END OF THE GUIDEWIRE LUMEN HAD A CLEAN CUT INDICATING THE GUIDEWIRE LUMEN DID NOT BREAK. THE LEADING OLIVE WAS FIRMLY ATTACHED TO THE POLYIMIDE GUIDEWIRE LUMEN. NO DAMAGE WAS OBSERVED TO THE TRAILING END OF THE LEADING OLIVE. THE FINDINGS FROM THE EVALUATION ARE CONSISTENT WITH THE PHYSICIAN¿S OBSERVATION FOR LEADING END OF THE CATHETER BROKEN. THE LIKELY CAUSE FOR THE BROKEN LEADING END OF THE CATHETER COULD NOT BE DETERMINED WITH THE CURRENTLY AVAILABLE INFORMATION

    Additional Manufacturer Narrative · 0

    (B)(4). 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) 2022, THE PATIENT WAS ADMITTED FOR TREATMENT OF AN ANEURYSM RUPTURE AND GRAFT REPAIR OF A NON-GORE GRAFT. AS REPORTED, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. AS REPORTED, THE GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT WAS FULLY DEPLOYED. AS REPORTED, DURING CATHETER WITHDRAWAL SOME RESISTANCE WAS FELT. AS REPORTED, THE LEADING OLIVE TIP HAD DETACHED FROM THE CATHETER. AS REPORTED, AN ATTEMPT WAS MADE TO ADVANCE THE SHEATH FOR RETRIEVAL OF THE OLIVE TIP, BUT THIS WAS NOT SUCCESSFUL. AS REPORTED, THE OLIVE WAS SUCCESSFULLY SNARED AND REMOVED FROM THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE. AS REPORTED, THERE WAS A TIGHT BEND IN THE ILIAC ARTERY WHERE THE OLIVE DETACHED. THE CATHETER AND OLIVE WERE SAVED FOR RETURN TO GORE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402989 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. PLC161000 00733132618668

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Unknown Other