BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS

    MDR report key: 14194434 · Received April 25, 2022

    Report

    Report Number
    3007284313-2022-01879
    Event Type
    Injury
    Date Received
    April 25, 2022
    Date of Event
    March 31, 2022
    Report Date
    February 3, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132651061
    PMA / PMN Number
    P200030
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS IMAGES WERE RETURNED FOR EVALUATION. THE EVALUATION STATED: THE IMAGES RECEIVED CANNOT BE USED TO PERFORM A FULL IMAGING EVALUATION BECAUSE THEY DO NOT MEET THE DICOM STANDARD. THE EXTENT AND ACCURACY OF THE OBSERVATIONS AND FINDINGS MAY BE LIMITED DUE TO THE COMPLETENESS, FORMAT AND/OR QUALITY OF THE IMAGES PROVIDED FOR REVIEW. GORE CANNOT GUARANTEE THE IMAGES PROVIDED ARE COMPLETE, ACCURATE OR LACK ALTERATION. THEREFORE, GORE CANNOT GUARANTEE ALL KEY FINDINGS HAVE BEEN CAPTURED OR THAT THE FINDINGS ARE ACCURATE. IMAGE RECEIVED VIA EMAIL, 3 JPGS. IMAGE CANNOT BE MANIPULATED IN ANYWAY. UNABLE TO CONFIRM KINKING WITH AVAILABLE IMAGES.

    Additional Manufacturer Narrative · 0

    H1: TYPE OF EVENT REVISED FROM PRODUCT MALFUNCTION TO SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    B1: REVISED TO SERIOUS INJURY. G3/G4: CORRECTED 510(K)PMA NUMBER FROM P020004 TO P20003.

    Description of Event or Problem · 0

    ON (B)(6) 2022, THE PATIENT WAS TREATED FOR A ABDOMINAL AORTIC ANUERYSM. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM. ALTHOUGH PATIENT ANATOMY WAS GOOD FOR THE PROCEDURE, THE GATE OF THE DEVICE KINKED WHEN IT WAS DEPLOYED. EFFORTS WERE MADE TO UNKINK THE DEVICE, INCLUDING REPOSITIONING, BUT THE KINK REMAINED. EVENTUALLY, THE PHYSICIAN CONVERTED TO AN AUI. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127445 GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. CXT321414 00733132651061

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Required Intervention