BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 21930322 · Received April 29, 2025

    Report

    Report Number
    3013164176-2025-02496
    Event Type
    Injury
    Date Received
    April 29, 2025
    Date of Event
    April 10, 2025
    Report Date
    May 21, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132618583
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDED B5, G3/G4, H1/H2, H6.

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), COMPLICATIONS ASSOCIATED MAY INCLUDE BUT ARE NOT LIMITED TO: NEUROLOGIC DAMAGE, LOCAL OR SYSTEMIC (E .G. PARAPLEGIA). 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 RESULTS OF THE NICKEL TEST WERE FOUND TO BE NEGATIVE.

    Description of Event or Problem · 0

    THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESES IN ZONE 9. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT FOLLOWING THE PROCEDURE, THE PATIENT WOKE UP FROM THE ANESTHESIA WITH BILATERAL PARAPLEGIA OF THE LEGS. THEY COULD NOT MOVE EITHER LEG. THEY ALSO HAD A RASH FROM THE MIDDLE OF THEIR BACK ALL THE WAY DOWN BOTH LEGS. THERE IS SUSPICION OF A NICKEL ALLERGY OR SENSITIVITY. THE PATIENT WAS GIVEN A SPINAL DRAIN TO TRY AND ADDRESS THE PARAPLEGIA. THEY DID A NICKEL TEST (AWAITING THOSE RESULTS) AND THEN GAVE HIGH A DOSE OF STEROIDS TO ADDRESS THE POTENTIAL NICKEL SENSITIVITY. THEY ARE STILL AWAITING THE RESULTS OF THE NICKEL TEST. ON AN UNKNOWN DATE, AN MRI WAS TAKEN AND IT WAS FOUND THAT THERE WAS EMBOLIZATION TO ONE OF THE ARTERIES FEEDING THE SPINAL CORD. THIS PROBABLY RESULTED FROM THE PHYSICIAN LEAVING A CATHETER BEHIND THE GRAFT WHEN IT WAS DEPLOYED. HE ALSO PERFORMED THIS TECHNIQUE USING A GEL FOAM SLURRY (FORM OF EMBOLIZATION) OF THE ANEURYSM SAC. THE PARALYSIS HAS NOT IMPROVED. THE EXACT CAUSE OF THE PARAPLEGIA IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1595670 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132618583

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention