BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 15792532 · Received November 14, 2022

    Report

    Report Number
    3013164176-2022-01537
    Event Type
    Injury
    Date Received
    November 14, 2022
    Date of Event
    September 19, 2022
    Report Date
    May 17, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132618545
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS ILIAC BRANCH COMPONENT - SN (B)(4); GORE® EXCLUDER® AAA ENDOPROSTHESIS - SN (B)(4); GORE® EXCLUDER® AAA ENDOPROSTHESIS - SN (B)(4). DEVICE REMAINS IMPLANTED AND IS UNAVAILABLE FOR MANUFACTURER EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET PRE-RELEASE SPECIFICATIONS. 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. 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

    A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET PRE-RELEASE SPECIFICATIONS. IMAGING PROVIDED IS AN ARTERIAL PHASE, POST-IMPLANT CTA. NON-CON AND DELAY PHASES NOT AVAILABLE. THERE IS < 1 CM OF OVERLAP BETWEEN THE DISTAL END OF THE CONTRALATERAL LIMB AND THE PROXIMAL END OF THE IBE COMPONENT. THERE IS A CONTRAST-LIKE DENSITY PRESENT OUTSIDE OF THE DEVICE, CANNOT CONFIRM CONTRAST WITHOUT A NON-CONTRAST CT AVAILABLE FOR COMPARISON. HOWEVER, IF CONTRAST COULD BE CONFIRMED, THIS WOULD BE CONSISTENT WITH THE REPORTED TYPE III ENDOLEAK, LIKELY DUE TO THE LACK OF OVERLAP BETWEEN COMPONENTS. THERE ARE PATENT LUMBARS PRESENT AT THE LEVEL OF THE IMPLANTED DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WAS TREATED FOR A LEFT ILIAC ANEURYSM WITH A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS ON (B)(6) 2022. THE PATIENT TOLERATED THE PROCEDURE. ON SEPTEMBER 19, CT IMAGING APPEARED TO SHOW THAT THE CONTRALATERAL LEG WAS SEPARATED FROM OR WAS NOT PLACED OPTIMALLY IN THE ILIAC BRANCH COMPONENT, CAUSING A TYPE III ENDOLEAK. THE ENDOPROSTHESES ARE PLANNED TO BE RELINED ON (B)(6) 2022.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WAS TREATED FOR A LEFT ILIAC ANEURYSM WITH A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS ON (B)(6) 2022. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) CT IMAGING APPEARED TO SHOW THAT THE CONTRALATERAL LEG WAS SEPARATED FROM OR WAS NOT PLACED OPTIMALLY IN THE ILIAC BRANCH COMPONENT, CAUSING A TYPE III ENDOLEAK. THE TYPE III ENDOLEAK WAS TREATED WITH RELINING ON (B)(6) 2022. AN ENDOLEAK PERSISTED AFTER THE REINTERVENTION. IT IS NOW THOUGHT THE PATIENT IS PRESENTING WITH A TYPE II ENDOLEAK. NO FURTHER REINTERVENTION IS PLANNED. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1859541 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. PLC271200 00733132618545

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other SEE H10.