BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 22052016 · Received May 20, 2025

    Report

    Report Number
    3013164176-2025-02526
    Event Type
    Injury
    Date Received
    May 20, 2025
    Date of Event
    April 25, 2025
    Report Date
    May 20, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132618538
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. H6: CODE B20 -THE DEVICE REMAINS IMPLANTED AND WAS THEREFORE NOT AVAILABLE FOR ENGINEERING EVALUATION BY GORE. ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU) STATE ¿ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE BUT ARE NOT LIMITED TO ENDOLEAKS AND ANEURYSM ENLARGEMENT. IMAGING EVALUATION SUMMARY: THE IMAGING EVALUATION PERFORMED BY A CLINICAL IMAGING SPECIALIST SHOWED THE FOLLOWING: ONE TIME-POINT AVAILABLE FOR EVALUATION: POST-IMPLANTATION CT DATED ON (B)(6) 2025 WITHOUT CONTRAST. CANNOT ASSESS FOR ENDOLEAKS, WITHOUT CONTRAST. IMAGES PROVIDED DO NOT ALLOW FOR EVALUATION IN RELATION TO THE REPORTED COMPLAINT. 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) 2022, THE PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) PROCEDURE UTILIZING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND TWO GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2025, FIELD SALES ASSOCIATE WAS NOTIFIED BY THE PHYSICIAN THAT THE PATIENT WITH A PREVIOUS GORE GRAFT HAS A TYPE 1B AND SUSPECTED POSSIBLE TYPE 1A ENDOLEAK PER CT SCANS. THE TYPE 1B ENDOLEAK IS ON THE LEFT LIMB AND PHYSICIAN PLANS TO DO A COIL EMBOLIZE OF THE LEFT HYPOGASTRIC ARTERY AND EXTEND INTO THE LEFT EXTERNAL ILIAC ARTERY UTILIZING A CONTRALATERAL LEG ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT UNDERWENT THE REINTERVENTION PROCEDURE FOR THE TYPE 1B ENDOLEAK ON THE LEFT SIDE. DURING THE PROCEDURE, ANGIO WAS TAKEN WHICH SHOWED NO LEAKS FROM TOP PROXIMAL SIDE, THEREFORE, THE PHYSICIAN ELECTED NOT TO DO ANYTHING UP THERE BECAUSE HE DID NOT SEE A TYPE 1A LEAK. PHYSICIAN STATED THERE IS A 9CM AAA AND THE LEFT LIMB WAS COMPLETELY OFF THE WALL CAUSING THE LEAK. PROCEDURE WENT WELL AND PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149948 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132618538

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Male Required Intervention