BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS

    MDR report key: 17463360 · Received August 4, 2023

    Report

    Report Number
    3007284313-2023-02678
    Event Type
    Malfunction
    Date Received
    August 4, 2023
    Date of Event
    July 12, 2023
    Report Date
    September 1, 2023
    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

    DEVICE WAS RETURNED, AND A PRODUCT EVALUATION WAS PERFORMED. PRODUCT EVALUATION SUMMARY PROVIDED THE FOLLOWING INFORMATION: · ENGINEERING FOUND THE DEVICE WAS UNABLE TO BE DEPLOYED VIA THE DEPLOYMENT KNOB UPON RECEIPT OF THE DEVICE. · ENGINEERING WAS ABLE TO INTRODUCE A MINIMAL AMOUNT OF SLACK IN THE DEPLOYMENT LINE AT THE DISTAL END OF THE ENDO. WHEN THE KNOB WAS PULLED OUT THE SMALL AMOUNT IT COULD BE, THAT SLACK WAS ELIMINATED INDICATING THE RESISTANCE WAS OCCURRING AT THE SLEEVE AND NOT WITHIN THE HANDLE. · THE SLEEVE WAS EXAMINED, AND ENGINEERING FOUND THAT THE STITCH LINE DID NOT CONTAIN ANY INCORRECT STITCHES OR LACING PATTERNS. NO ABNORMALITIES WERE IDENTIFIED ON THE SLEEVE THAT COULD HAVE RESULTED IN THE INABILITY TO DEPLOY THE DEVICE. · ENGINEERING WAS ABLE TO MOVE THE FIBER ALONG THE STITCH LINE AS WOULD OCCUR DURING THE MANUFACTURING PROCESS. AFTER MOVING THE FIBER ALONG THE STITCH LINE, ENGINEERING WAS ABLE TO FULLY DEPLOY THE PRIMARY DEPLOYMENT KNOB WITH NORMAL FORCE. RESISTANCE WAS NOT FACED. BASED ON THE FINDINGS OF THIS EVALUATION, ENGINEERING WAS ABLE TO CONFIRM THE EVENT THAT THE PHYSICIAN ¿TRIED TO REMOVE THE DEPLOYMENT KNOB, AND IMMEDIATELY RESISTANCE WAS FELT. PHYSICIAN ATTEMPTED TO PULL HARDER AND STILL COULD NOT GET THE DEPLOYMENT LINE TO DEPLOY THE DEVICE.¿ THE ROOT CAUSE OF THIS INABILITY TO DEPLOY THE DEVICE COULD NOT BE CONFIRMED WITH THE AVAILABLE INFORMATION. NO MANUFACTURING DEFICIENCY WAS IDENTIFIED, THEREFORE, NO CAPA REQUEST WILL BE GENERATED PER (B)(4), ENGINEERING EVALUATION TASK PROCEDURE, REVISION 27. THIS TYPE OF EVENT WILL CONTINUE TO BE MONITORED PER (B)(4).

    Additional Manufacturer Narrative · 0

    H6: CODE B01-DEVICE WILL BE RETURNED. PENDING COMPLETION OF ENGINEERING ANALYSIS. H6: CODE C19-A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET ALL PRE-RELEASE MANUFACTURING SPECIFICATIONS. NO DEVICE PROBLEM WAS FOUND PER REVIEW OF THESE RECORDS. 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) 2023, PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM UTILIZING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. DURING THE PROCEDURE, DEVICE WAS PLACED BELOW THE RENAL ARTERIES. THE PHYSICIAN WENT TO START DEPLOYMENT AND ROTATED THE HANDLE COUNTERCLOCKWISE, TRIED TO REMOVE THE DEPLOYMENT KNOB, RESISTANCE WAS FELT. PHYSICIAN ATTEMPTED TO PULL HARDER AND STILL COULD NOT DEPLOY THE DEVICE. ANOTHER CONFORMABLE DEVICE WAS USED TO COMPLETE THE PROCEDURE. PATIENT TOLERATED THE PROCEDURE. PHYSICIAN DOES KNOW WHAT CAUSED THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1953438 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 90 YR Male Other