BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS

    MDR report key: 17818729 · Received September 26, 2023

    Report

    Report Number
    3007284313-2023-02771
    Event Type
    Malfunction
    Date Received
    September 26, 2023
    Date of Event
    September 13, 2023
    Report Date
    October 13, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132651078
    PMA / PMN Number
    P020004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE AND SHEATH WERE RETURNED TO GORE FOR EVALUATION. THE DEVICE EVALUATION PERFORMED BY ENGINEERING SHOWED THE DRYSEAL FLEX INTRODUCER SHEATH LEADING END EXHIBITED DAMAGE AND INWARD FOLDING, WHICH PREVENTED THE EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS LEADING TIP FROM BEING WITHDRAWN THROUGH THE INTRODUCER SHEATH. NO DAMAGE OR ABNORMALITIES WERE OBSERVED TO THE CATHETER INNER MEMBER OR THE LEADING TIP OF THE EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. BASED ON THE FINDINGS FROM THE EVALUATION AND THE DAMAGE AND FOLDING TO THE INTRODUCER, ALONG WITH ENGINEERING¿S INABILITY TO RETRACT THE LEADING TIP THROUGH THE SHEATH, THE REPORTED OBSERVATION THAT ¿THE OLIVE TIP WAS NOT RETRACTING INTO THE SHEATH¿ CAN BE CONFIRMED. THE INABILITY TO RETRACT IS LIKELY DUE TO THE INTERACTION BETWEEN THE DAMAGED AND FOLDED SHEATH AND THE EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS LEADING TIP. THERE WAS NO ROOT CAUSE IDENTIFIED FOR THE CAUSE OF THE SHEATH DAMAGE AND FOLDING. THERE WAS NO EVIDENCE OF MANUFACTURING DEFICIENCY FOR THE EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS IDENTIFIED THROUGH THE EVALUATION.

    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.

    Description of Event or Problem · 0

    THE GORE FIELD SALES ASSOCIATE REPORTED THE FOLLOWING: ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES. IT WAS REPORTED THAT DURING THE PROCEDURE WHEN ATTEMPTING TO RETRACT THE DELIVERY CATHETER OF GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS THROUGH THE GORE® DRYSEAL FLEX INTRODUCER SHEATH (18FR) THE OLIVE TIP WAS NOT RETRACTING INTO THE SHEATH. THE SHEATH WAS REMOVED WITH THE DELIVERY CATHETER, NO INJURY TO THE PATIENT. A NEW SHEATH WAS USED FOR THE REMAINDER OF THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973558 GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132651078

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Male Hospitalization