BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS

    MDR report key: 13114635 · Received December 29, 2021

    Report

    Report Number
    3007284313-2021-01732
    Event Type
    Injury
    Date Received
    December 29, 2021
    Date of Event
    December 22, 2021
    Report Date
    March 16, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132651030
    PMA / PMN Number
    P200030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G3/G4, PMA/510K NUMBER INCORRECTLY ENTERED PREVIOUSLY AND CHANGED TO P200030.

    Additional Manufacturer Narrative · 0

    H6 CODE 213 - NO DEVICE PROBLEM FOUND: A REVIEW OF MANUFACTURING RECORDS VERIFIED THAT THE LOT INVOLVED IN THIS COMPLAINT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 0

    ON (B)(6) 2021 THE PATIENT UNDERWENT TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE ® EXCLUDER ® CONFORMABLE AAA ENDOPROSTHESIS (CXT261412) AND WITH GORE ® EXCLUDER ® AAA ENDOPROSTHESES (PLC14100, PLC201200, AND PLC121400). THE PLC 121400 WAS EXTENDED INTO THE IPSILATERAL LIMB ON THE RIGHT SIDE OF THE PATIENT. A 3CM OF OVERLAP WAS OBSERVED BETWEEN THE CXT261412 AND THE PLC121400 AT THE TIME OF THE PROCEDURE. A FOLLOW UP CT SCAN WAS PERFORMED ON AN UNSPECIFIED DATE AND IT WAS OBSERVED THAT THE THERE WAS NO OVERLAP BETWEEN CXT261412 AND THE PLC121400 ENDOPROSTHESES. THE PLC121400 HAD MIGRATED TO THE END OF THE IPSILATERAL LIMB ON THE CXT261412. A TYPE III ENDOLEAK WAS OBSERVED. ON (B)(6) 2021 A REINTERVENTION WAS PERFORMED IN WHICH A PLC 161400 WAS IMPLANTED TO TREAT THE TYPE III ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE AND THE ENDOLEAK WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2009960 GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. CXT261412 00733132651030

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention| H| O