BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 16040279 · Received December 22, 2022

    Report

    Report Number
    2017233-2022-03598
    Event Type
    Injury
    Date Received
    December 22, 2022
    Date of Event
    November 28, 2022
    Report Date
    January 19, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132622535
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), POTENTIAL ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO CONVERSION, ENDOPROSTHESIS OR DELIVERY SYSTEM: COMPONENT MIGRATION.

    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.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO GORE BY CLINICAL SPECIALIST. ON (B)(6) 2015, PATIENT UNDERWENT AN UNKNOWN PROCEDURE UTILIZING TWO GORE EXCLUDERS RLT281414 (RIGHT) AND PXC121200 (LEFT). PRIOR TO THE IMPLANT IN 2015, PATIENT SUFFERED FROM RIGHT LOWER EXTREMITY ISCHEMIA DUE TO EMBOLIZATION FROM ABDOMINAL AORTIC ANEURYSM. PATIENT ALSO DIAGNOSED WITH LUNG CANCER THAT RADIOLOGY/ONCOLOGY REFUSED TO TREAT UNTIL ANEURYSM WAS ADDRESSED. ACCORDING TO THE PHYSICIAN, THE AORTIC ANATOMY WAS NOT IDEAL FOR ENDOVASCULAR REPAIR BUT WAS LIKELY PATIENT¿S BEST OPTION CONSIDERING COMORBIDITIES AND URGENCY TO BEGIN CANCER TREATMENT. PATIENT HAD SHORT, REVERSE TAPERED NECK WITH THE AORTIC DIAMETER AT THE RENALS WAS 18MM AND QUICKLY DILATED TO ~30MM OVER 12MM LENGTH. DURING A FOLLOW-UP SOMETIME IN (B)(6) 2022 (DATE UNKNOWN), THE PATIENT PRESENTED WITH GRAFT MIGRATION / DISEASE PROGRESSION PROXIMAL EDGE OF THE GRAFT MIGRATED DOWN (DISTALLY) AT THE LEVEL OF THE RENALS AND DID NOT COVER THE RENALS. AORTIC DIAMETER AT RENALS HAD GROWN TO 4-5CM. THE ORIGINAL GRAFT MIGRATED ~3CM. ON (B)(6) 2022, THE PATIENT WAS TREATED WITH OPEN REPAIR; GRAFT EXPLANT WAS PERFORMED. PROCEDURE WAS SUCCESSFUL WITH NO HARM TO THE PATIENT. POST-SURGERY FOLLOW-UP DATE IS UNKNOWN. THE EXPLANTED GRAFT WAS NOT SAVED FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2139905 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. RLT281414 00733132622535

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention| H