BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 3777974 · Received April 29, 2014

    Report

    Report Number
    2953161-2014-00049
    Event Type
    Injury
    Date Received
    April 29, 2014
    Date of Event
    April 1, 2014
    Report Date
    October 9, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH THREE GORE EXCLUDER AAA ENDOPROSTHESES. IT WAS REPORTED, THE TRUNK WAS IMPLANTED FROM THE RIGHT SIDE WITH EXTENSION OF THE IPSILATERAL LEG INTO THE COMMON ILIAC ARTERY WITH NO ISSUE. PRE-OPERATIVE IMAGING (DATE UNKNOWN) IDENTIFIED INCREASED DILATION OF THE RIGHT COMMON ILIAC ARTERY. IT WAS DETERMINED THE INCREASED DILATION WOULD PREVENT ADEQUATE SEAL OF THE GRAFT. THE PHYSICIAN ELECTED TO COIL EMBOLIZED AND INTENTIONALLY COVERED THE RIGHT HYPOGASTRIC ARTERY WITH A CONTRALATERAL LEG COMPONENT (PXC141200) AS IT WAS REPORTED THE LEFT HYPOGASTRIC ARTERY WAS FULLY PATENT. FINAL ANGIOGRAPHY SHOWED A POSSIBLE PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN ELECTED TO CONCLUDE THE PROCEDURE AND WILL MONITOR THE ENDOLEAK WITH FOLLOW-UP IMAGING. ON (B)(6) 2014, FOLLOW-UP CT IMAGING SHOWED THE PROXIMAL TYPE I ENDOLEAK REMAINED. ADDITIONALLY, KINKING OF THE RIGHT CONTRALATERAL LEG COMPONENT WAS ALSO NOTED. REPORTEDLY, THE PXC WAS KINKED APPROXIMATELY 40 MM PROXIMAL OF THE DISTAL END OF THE DEVICE AND NOT IN THE AREA OF THE OVERLAP BETWEEN THE PCX AND RMT DEVICES. FURTHER, IT WAS NOTED THAT THE PXC HAD BECOME OBSTRUCTED AS A RESULT OF THE KINK. IT IS BELIEVED THE PATIENT'S TORTUOUS ANATOMY CAUSED THE PXC TO KINK. ON APRIL 2, 2014, AN INTERVENTION WAS PERFORMED TO TREAT THE KINKED LIMB. A BALLOON-EXPANDABLE STENT WAS IMPLANTED WITHIN THE GRAFT. FINAL ANGIOGRAPHY SHOWED RESOLUTION OF THE KINKED LIMB, AND THE PATIENT TOLERATED THE PROCEDURE. AT THE PRESENT TIME AN INTERVENTION IS NOT PLANNED TO TREAT THE ENDOLEAK. THE PHYSICIAN WILL CONTINUE TO MONITOR THE ENDOLEAK WITH FOLLOW-UP IMAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257649 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 12205677

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R MEDICATIONS: ASCAL