BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 20553695 · Received October 29, 2024

    Report

    Report Number
    3007284313-2024-03543
    Event Type
    Injury
    Date Received
    October 29, 2024
    Date of Event
    October 17, 2024
    Report Date
    October 29, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: CODE "OTHER" WAS SELECTED AS THE MEDICAL DEVICE REMAINS IMPLANTED. RETURN NOT POSSIBLE. H6: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. H6: CODE D1102: IFU STATEMENTS. THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU) WERE REVIEWED WITH RESPECT TO THE COMPLAINT DETAIL FOR THE APPLICABLE REGION AND TIME PERIOD, AND THE FOLLOWING IFU STATEMENTS WERE IDENTIFIED IN RELATION TO THE REPORTED DEPLOYMENT TECHNIQUE OF PUSHING THE DEVICE UP DURING DEPLOYMENT. [POSITIONING AND DEPLOYMENT OF THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS] 14. STABILIZE THE DELIVERY CATHETER AT THE ENTRY LEVEL INTO THE INTRODUCER SHEATH AND SECURE THE SHEATH TO THE PATIENT'S ACCESS SITE. VERIFY THAT THE CONSTRAINING DIAL CANNOT BE ROTATED COUNTER-CLOCKWISE. THEN ROTATE THE CLEAR KNOB 90° COUNTER-CLOCKWISE BY SLIDING THE RED SAFETY LOCK AND REMOVE THE CLEAR KNOB STRAIGHT OUT FROM THE CATHETER HANDLE (FIGURE 8). IN THE EVENT THAT THE REMOVAL OF THE CLEAR KNOB DOES NOT INITIATE THE REMOVAL OF THE CONSTRAINING/REOPENING MECHANISM AND THE PROBLEM IS SUSPECTED TO HAVE OCCURRED IN THE DEPLOYMENT HANDLE, FOLLOW STEP 2 IN THE [BACKUP DEPLOYMENT MECHANISM] 15. LOOSEN THE DISTAL DEPLOYMENT KNOB, PULL THE KNOB GENTLY AND STEADILY WITHOUT A STOP, AND OPEN THE IPSILATERAL LEG OF THE DEVICE. THIS OPENING ACTION OF THE KNOB WILL LEAD TO COMPLETION IN DEPLOYING THE TRUNK-IPSILATERAL LEG. IN THE EVENT THAT THE REMOVAL OF THE DISTAL DEPLOYMENT KNOB DOES NOT INITIATE THE DEPLOYMENT OF THE IPSILATERAL LEG AND THE PROBLEM IS SUSPECTED TO HAVE OCCURRED IN THE DEPLOYMENT HANDLE, FOLLOW STEP 3 IN THE [BACKUP DEPLOYMENT MECHANISM]. 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) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WITH ILIAC ANEURYSM USING GORE® EXCLUDER®AAA ENDOPROSTHESES. WHEN THE TRUNK-IPSILATERAL LEG WAS DEPLOYED, THE IPSILATERAL LEG OF TRUNK-IPSILATERAL LEG UNINTENTIONALLY COVERED THE PART OF RIGHT INTERNAL ILIAC ARTERY. IT WAS REPORTED THAT THE PHYSICIAN HAD TRIED TO PUSH THE DEVICE UP DURING THE DEPLOYMENT, BUT IT WAS NOT SUCCESSFUL. A FEW MILLIMETERS OF THE RIGHT INTERNAL ILIAC ARTERY WAS COVERED BY THE DISTAL LEG. DELAYED BLOOD FLOW TO THE RIGHT INTERNAL ILIAC ARTERY WAS OBSERVED, BUT NO TREATMENT WAS PERFORMED. THE PROCEDURE WAS COMPLETED, AND THE PATIENT WAS DECIDED TO BE MONITORED. THE PHYSICIAN MENTIONED THAT HE FAILED TO PUSH UP THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303249 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Male Other