BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS

    MDR report key: 20311481 · Received September 26, 2024

    Report

    Report Number
    3007284313-2024-03495
    Event Type
    Injury
    Date Received
    September 26, 2024
    Date of Event
    September 3, 2024
    Report Date
    December 20, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132651054
    PMA / PMN Number
    P200030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    UPDATED B.5. DESCRIPTION OF EVENT. UPDATED H.6. INVESTIGATION CONCLUSIONS TO CODE D14. H.6. INVESTIGATION CONCLUSIONS: ACCORDING TO THE PHYSICIAN, THERE REPORTED EVENT WAS UNRELATED TO THE IMPLANTED DEVICES. THEREFORE, THERE IS NO ALLEGATION OF DEFICIENCY AGAINST THIS DEVICE, AND THE REPORT IS BEING RETRACTED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS TRUNK AND GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2024 THE PATIENT CALLED IN REQUESTING HIS PATIENT ID CARD. LATER THAT DAY, THE PATIENT CALLED AGAIN TO CONFIRM THE REQUEST. DURING THAT CALL, HE MENTIONED THAT HE HAD BEEN SCHEDULED FOR AN MRI THAT DAY, BUT THAT THEY WOULDN'T SEE HIM WITHOUT THE PATIENT ID CARD. THE PATIENT REPORTED THAT SINCE THE SURGERY, HE HAD BECOME UNABLE TO WALK, AND WAS DESPERATE TO GET THE MRI THIS WEEK BECAUSE OF HOW MUCH PAIN HE WAS IN. ON (B)(6) 2024, THE PATIENT RECEIVED AN MRI. REPORTEDLY, THERE WAS NO OBVIOUS CAUSE FOR THE PAIN THAT COULD BE FOUND ON THE MRI. THE PATIENT IS SCHEDULED FOR A SONOGRAM ON (B)(6) 2024. ON A CALL, THE PATIENT REPORTED THE SYMPTOMS AS FOLLOWS: SOMETIMES WHEN I'M WALKING, MY LEGS JUST STOP WORKING, LIKE WHEN YOU HAVE LACTIC ACID BUILD UP OR WHEN THEY ARE FALLING ASLEEP, EXCEPT EXTREME PAIN IN BOTH LEGS.

    Description of Event or Problem · 0

    ON OCTOBER 29TH, A GORE REPRESENTATIVE SPOKE TO THE PHYSICIAN. ACCORDING TO THE PHYSICIAN, THE PATIENT SYMPTOMS ARE NOT RELATED TO THE GORE DEVICE OR TO THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1292160 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 76 YR Male Disability