BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 20674811 · Received November 13, 2024

    Report

    Report Number
    3007284313-2024-03580
    Event Type
    Injury
    Date Received
    November 13, 2024
    Date of Event
    October 18, 2024
    Report Date
    November 27, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132610150
    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

    AS IT IS UNKNOWN WHICH DEVICE IS DIRECTLY IMPLICATED IN THIS ENDOLEAK EVENT, THE FOLLOWING DEVICES WILL ALSO BE INCLUDED IN THIS REPORT: CATALOG#: PXL161407/ SERIAL#: (B)(6)/ UDI#: (B)(4). CATALOG#: PXC161000/ SERIAL#: (B)(6)/ UDI#: (B)(4). H6: CODE C19-A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET ALL PRE-RELEASE MANUFACTURING SPECIFICATIONS. AS THE DEVICE WAS NOT ACCESSIBLE, THE PRODUCT HISTORY REVIEW (PHR) REVIEW WAS THE EXTEND OF THE INVESTIGATION. NO DEVICE PROBLEM WAS FOUND PER REVIEW OF THESE RECORDS. IT SHOULD BE NOTED THAT, PER THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO, ENDOLEAK. PATIENT MEDICATION INCLUDES: ASA 81MG PO Q DAY, ATORVASTATIN 80MG PO Q DAY, EMPAGLIFLOZIN 10MG Q DAY, FINASTERIDE 5 MG PO Q DAY, LISINOPRIL 40MG PO Q DAY, METFORMIN 500MG PO Q DAY, RIBAROZABAN 20MG PO Q DAY, SIMETHICONE 125MG PO Q DAY, SOTALOL 80MG PO Q DAY. 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 SECTION B5, G3/G4, AND H10. PATIENT CO-MORBIDITIES INCLUDE: AAA. CAD. HTN. HX OF PE (2005). DIABETES.

    Description of Event or Problem · 0

    ON (B)(6) 2005, PATIENT UNDERWENT AN UNKNOWN ENDOVASCULAR PROCEDURE UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (PXT231416, PXL161407, AND PXC161000 WERE IMPLANTED). ON AN UNKNOWN DATE, AND ENDOLEAK WAS OBSERVED. THE TYPE OF ENDOLEAK AND LOCATION OF ENDOLEAK REMAINS UNKNOWN. ON (B)(6) 2024, PATIENT UNDERWENT A REINTERVENTION PROCEDURE TO TREAT THIS ENDOLEAK. PHYSICIAN RELINED AN EXCLUDER GRAFT. PATIENT TOLERATED THE PROCEDURE.

    Description of Event or Problem · 0

    ON (B)(6)2005, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM. ON (B)(6)2024, PATIENT UNDERWENT A REINTERVENTION PROCEDURE TO TREAT THIS ENDOLEAK. PHYSICIAN RELINED AN EXCLUDER GRAFT. TWO EXCLUDER CONTRALATERAL COMPONENTS (PLC141000, PLC141400, AND PLL161407) ONE EXCLUDER ILIAC EXTENDER WERE IMPLANTED. MULTIPLE ATTEMPTS WERE MADE TO THE PHYSICIAN TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2314469 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132610150

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Unknown Required Intervention