BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 18748059 · Received February 21, 2024

    Report

    Report Number
    3013164176-2024-01986
    Event Type
    Injury
    Date Received
    February 21, 2024
    Date of Event
    January 25, 2024
    Report Date
    April 9, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. CODE E2402: USED TO CAPTURE ILIAC ARTERY DILATION. ACCORDING TO THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, THE PHYSICIAN AND PATIENT SHOULD REVIEW THE RISKS AND BENEFITS WHEN DISCUSSING THIS ENDOVASCULAR DEVICE AND PROCEDURE INCLUDING: THE POSSIBILITY THAT SUBSEQUENT INTERVENTIONAL OR OPEN SURGICAL REPAIR OF THE ANEURYSM MAY BE REQUIRED AFTER INITIAL ENDOVASCULAR REPAIR. 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

    ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, THE PHYSICIAN AND PATIENT SHOULD REVIEW THE RISKS AND BENEFITS WHEN DISCUSSING THIS ENDOVASCULAR DEVICE AND PROCEDURE INCLUDING: THE POSSIBILITY THAT SUBSEQUENT INTERVENTIONAL OR OPEN SURGICAL REPAIR OF THE ANEURYSM MAY BE REQUIRED AFTER INITIAL ENDOVASCULAR REPAIR. CHANGED ADDITIONAL MANUFACTURE NARRATIVE FROM: ACCORDING TO THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, THE PHYSICIAN AND PATIENT SHOULD REVIEW THE RISKS AND BENEFITS WHEN DISCUSSING THIS ENDOVASCULAR DEVICE AND PROCEDURE INCLUDING: THE POSSIBILITY THAT SUBSEQUENT INTERVENTIONAL OR OPEN SURGICAL REPAIR OF THE ANEURYSM MAY BE REQUIRED AFTER INITIAL ENDOVASCULAR REPAIR. TO: ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, THE PHYSICIAN AND PATIENT SHOULD REVIEW THE RISKS AND BENEFITS WHEN DISCUSSING THIS ENDOVASCULAR DEVICE AND PROCEDURE INCLUDING: THE POSSIBILITY THAT SUBSEQUENT INTERVENTIONAL OR OPEN SURGICAL REPAIR OF THE ANEURYSM MAY BE REQUIRED AFTER INITIAL ENDOVASCULAR REPAIR.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2019, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON AN UNKNOWN DATE, THE LEFT COMMON ILIAC ARTERY, WHERE THE DISTAL END OF A CONTRALATERAL LEG ENDOPROSTHESIS (PLC231200J) HAD BEEN IMPLANTED, WAS FOUND TO HAVE BECOME ANEURYSMAL. ON (B)(6) 2024, A REINTERVENTION WAS PERFORMED. THE LEFT INTERNAL ILIAC ARTERY WAS EMBOLIZED AS PLANNED. THEN, TWO CONTRALATERAL LEG ENDOPROSTHESES WERE ADDED TO THE LEFT EXTERNAL ILIAC ARTERY TO EXTEND THE DISTAL END OF THE PREVIOUSLY IMPLANTED PLC231200J. THE CAUSE OF THE REPORTED EVENT IS UNKNOWN. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67432 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention