BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3437006 · Received October 22, 2013

    Report

    Report Number
    2953161-2013-00158
    Event Type
    Injury
    Date Received
    October 22, 2013
    Date of Event
    January 4, 2008
    Report Date
    September 30, 2013
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. CONCLUSIONS - THE PATIENT'S PROXIMAL NECK LENGTH WAS 8 MM AND ANGLE WAS 65 DEGREES. ACCORDING TO THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTION FOR USE, ANATOMICAL REQUIREMENTS FOR USE OF THE DEVICE INCLUDE AORTIC NECK LENGTH OF AT LEAST 15 MM AND PROXIMAL AORTIC NECK ANGULATION AND # 8804; 60 DEGREE.

    Description of Event or Problem · 1

    ON (B)(6) 2008, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESIS. IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN HAD A DIFFICULTY IN ADVANCING THE TRUNK-IPSILATERAL LEG COMPONENT AND MANIPULATING THE OTHER DEVICES. FINAL ANGIOGRAM SHOWED A PROXIMAL TYPE I ENDOLEAK, AND THE PHYSICIAN DECIDED TO MONITOR THE PATIENT. AFTER THE PROCEDURE ON THE SAME DAY, THE PATIENT DEVELOPED PARAPLEGIA. THE PHYSICIAN DECIDED TO MONITOR THE PATIENT. ON (B)(6) 2008, A POST PROCEDURE FOLLOW-UP IMAGE SHOWED THE PERSISTENT TYPE I ENDOLEAK. ON (B)(6) 2009, AN AORTIC EXTENDER COMPONENT WAS ADDITIONALLY IMPLANTED TO REPAIR THE PERSISTENT TYPE I ENDOLEAK. THE ENDOLEAK WAS RESOLVED AND THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2009, THREE MONTH FOLLOW UP EXAMINATION IDENTIFIED NO ENDOLEAK. NO FOLLOW UP EXAMINATION HAS BEEN PERFORMED SINCE THE PATIENT DID NOT VISIT THE HOSPITAL DUE TO THE PERSISTENT PARAPLEGIA. IT WAS REPORTED THAT THE PATIENT'S PROXIMAL NECK LENGTH WAS 8MM AND ANGLE WAS 65 DEGREES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540361 GORE EXCLUDER AAA ENDOPROSTHESIS MIH W. L. GORE & ASSOCIATES 05206142

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R PXA280300/05133606| PXC141400/05237777| PXL161407/05201644