BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 20765393 · Received November 22, 2024

    Report

    Report Number
    3007284313-2024-03611
    Event Type
    Injury
    Date Received
    November 22, 2024
    Date of Event
    October 25, 2024
    Report Date
    January 23, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132610297
    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 G3/G4, H1/H2, H6. THE EXCLUDER TRUNK IPSILATERAL LEG DEVICE INSTRUCTIONS FOR USE (IFU) WERE REVIEWED WITH RESPECT TO THE COMPLAINT DETAIL FOR THE APPLICABLE REGION AND TIME PERIOD, AND THE FOLLOWING IFU STATEMENTS WERE IDENTIFIED IN RELATION TO THE COMPLAINT. ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION OR ADDITIONAL INTRAOPERATIVE PROCEDURE TIME INCLUDE, BUT ARE NOT LIMITED TO: ENDOLEAK AND ENDOPROSTHESIS OR DELIVERY SYSTEM: COMPONENT MIGRATION.

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE ENDOLEAKS OR ENDOPROSTHESIS OR DELIVERY SYSTEM: COMPONENT MIGRATION. THE IMAGING EVALUATION DETERMINED THE FOLLOWING: THERE WAS A ONE TIME POINT AVAILABLE FOR EVALUATION: POST-IMPLANTATION CTA DATED (B)(6) 2024. THE LENGTH FROM THE LEFT RENAL ARTERY (LRA) TO THE PROXIMAL CIRCUMFERENTIAL IMPLANTED GORE® EXCLUDER® AAA ENDOPROSTHESIS APPEARS TO BE 11.8MM, BY CENTERLINE. THE AORTIC DIAMETER JUST DISTAL TO THE LEFT RENAL ARTERY (LRA) APPEARS TO BE 29.6MM. THE AORTIC DIAMETER ~8MM DISTAL TO THE LRA APPEARS TO BE 29.2MM. THE AORTIC DIAMETER 10MM DISTAL TO THE LRA APPEARS TO BE 29.6MM. THE AORTIC DIAMETER 15MM DISTAL TO THE LRA APPEARS TO BE 45.4MM. THERE IS THROMBUS WITHIN THIS 15MM OF ABDOMINAL AORTA. LARGE LUMBAR ARTERIES ARE VISUALIZED AT THE VERY PROXIMAL END OF THE IMPLANTED DEVICE. THE COMPARISON AXIAL SERIES IMAGING SHOWS: THERE IS CONTRAST COMMUNICATING BETWEEN A LUMBAR ARTERY AND THE ANEURYSM SAC ON THE ARTERIAL CONTRAST SERIES. THE CONTRAST IS POOLING INSIDE THE POSTERIOR ANEURYSM SAC AND IS INCREASED ON THE DELAYED CONTRAST SERIES. THEREBY, CONFIRMING A TYPE II ENDOLEAK INVOLVING A LUMBAR ARTERY. THERE IS CONTRAST OUTSIDE THE DISTAL CONTRALATERAL LIMB IN THE LEFT COMMON ILIAC (LCI) AND THERE IS LACK OF CIRCUMFERENTIAL DEVICE APPOSITION. THEREBY, CONFIRMING A DISTAL TYPE I ENDOLEAK. THE LENGTH FROM THE DISTAL CIRCUMFERENTIAL DEVICE LIMB IN THE LCI TO THE LEFT ILIAC BIFURCATION APPEARS TO BE 11MM, BY CENTERLINE. LCI DIAMETERS WITHIN THIS 11MM OF VESSEL APPEAR TO RANGE FROM 26.2MM ¿ 30.5MM. MIGRATION CANNOT BE CONFIRMED WITH THIS ONE TIME-POINT. THERE WAS NOT AN AORTIC EXTENDER PRESENT ON THIS TIME-POINT. 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 3007284313-2024-03611E 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

    ON (B)(6) 2010, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE UTILIZING THE GORE® EXCLUDER® AAA ENDOPROSTHESIS (2 CONTRALATERAL LEGS, TRUNK IPSILATERAL, AORTIC EXTENDER). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024, THE PHYSICIAN REPORTED A CASE REFERRED TO HIM INVOLVING A PREVIOUSLY IMPLANTED EXCLUDER EVAR WITH A SUSPECTED TYPE 1 AND POSSIBLE MIGRATION. THE PHYSICIAN STATED THAT A FENESTRATED CUFF WILL BE PLACED AND THAT NO OTHER GORE SUPPORT WAS NECESSARY. NO ADDITIONAL INFORMATION IS KNOWN OR AVAILABLE. THE IMAGING EVALUATION DETERMINED THE FOLLOWING: THERE IS CONTRAST OUTSIDE THE DISTAL CONTRALATERAL LIMB IN THE LCI AND THERE IS LACK OF CIRCUMFERENTIAL DEVICE APPOSITION. THEREBY, CONFIRMING A DISTAL TYPE I ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1799270 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132610297

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention