BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 17737271 · Received September 13, 2023

    Report

    Report Number
    3013164176-2023-01836
    Event Type
    Injury
    Date Received
    September 13, 2023
    Date of Event
    August 18, 2023
    Report Date
    September 27, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132618682
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. H6: CODE B20 -THE DEVICE REMAINS IMPLANTED AND WAS THEREFORE NOT AVAILABLE FOR ENGINEERING EVALUATION BY GORE. 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 ANEURYSM ENLARGEMENT, ENDOLEAK, AND REOPERATION. 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

    IMAGING EVALUATION SUMMARY: THE IMAGING EVALUATION PERFORMED BY A CLINICAL IMAGING SPECIALIST SHOWED THE FOLLOWING: ONE TIME-POINT AVAILABLE FOR EVALUATION: POST-IMPLANTATION CTA DATED (B)(6) 2023. THE MAXIMUM AAA DIAMETER APPEARS TO BE 86.4MM X 93.0MM. CANNOT CONFIRM ANEURYSM GROWTH WITH ONE TIME-POINT. CONTRAST IS VISUALIZED WITHIN THE POSTERIOR LEFT ABDOMINAL ANEURYSM SAC AND THE LEFT COMMON ILIAC ARTERY OUTSIDE THE IMPLANTED DEVICES. MAXIMUM DIAMETER OF THE LCI APPEARS TO BE 26.6MM. THERE IS LACK OF DEVICE/WALL APPOSITION IN THE LCI. THE FINDINGS ABOVE ARE CONSISTENT WITH A DISTAL TYPE 1 ENDOLEAK.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2017, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG AND CONTRALATERAL LEG). ON (B)(6), 2023 THE FIELD SALES ASSOCIATE (FSA) WAS NOTIFIED BY THE PHYSICIAN THAT THE PATIENT WILL UNDERGO A REINTERVENTION FOR A TYPE 1B ENDOLEAK ON THE CONTRALATERAL LEG (PLC201200). THERE IS GROWTH IN ANEURYSM SIZE AS THE AAA IS 9CM, PRIOR SIZE IS UNKNOWN BUT GROWTH HAS BEEN NOTICED THAT LED TO THE LEFT COMMON ILIAC ARTERY (LCIA) BEING DILATED AND ENLARGED. PHYSICIAN PLANS TO COIL THE LEFT INTERNAL ILIAC ARTERY (LIIA) AND EXTEND INTO THE LEFT EXTERNAL ILIAC ARTERY (LEIA). ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR REINTERVENTION PROCEDURE IN ZONE11-INTERNAL/EXTERNAL ILIAC TO TREAT THE TYPE 1B ENDOLEAK UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (CONTRALATERAL LEG AND ILIAC EXTENDER) BY COILING THE LEFT INTERNAL ILIAC ARTERY (LIIA) THEN THE PHYSICIAN EXTENDED DISTALLY WITH CONTRALATERAL LEG (PLC141200) FROM THE FLOW DIVIDER DOWN AND EXTENDED WITH ILIAC EXTENDER (PLL161007) INTO THE LEFT EXTERNAL ILIAC ARTERY (LEIA). REPORTEDLY, PHYSICIAN INDICATED THE CAUSE OF THE ENDOLEAK WAS THE LEFT COMMON ILIAC ARTERY (LCIA) BEING DILATED THAT LED TO POSSIBLE LEAK INTO THE ANEURYSM. ENDOLEAK WAS RESOLVED AND PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1789274 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132618682

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention| H