BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1202952 · Received October 16, 2008

    Report

    Report Number
    2017233-2008-00754
    Event Type
    Injury
    Date Received
    October 16, 2008
    Date of Event
    September 16, 2008
    Report Date
    October 16, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CODE: A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. CODE- THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. PER THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, THE DEVICE IS INTENDED TO TREAT INFRARENAL ABDOMINAL AORTIC ANEURYSM DISEASE IN PTS HAVING APPROPRIATE ANATOMY, INCLUDING A PROXIMAL AORTIC NECK ANGULATION OF LESS THAN OR EQUAL TO 60 DEGREES. AS REPORTED, THE DEVICE WAS UNABLE TO ACHIEVE SEAL, DUE TO THIS PRE-EXISTING PT ANATOMY. ADD'L, AS REPORTED, THE PROXIMAL TYPE I ENDOLEAK WAS NOT IDENTIFIED DURING THE PRIMARY PROCEDURE DUE TO THE POOR FLUOROSCOPIC IMAGE QUALITY. THE IFU STATES TO PERFORM EXTENDED IMAGING ANGIOGRAPHY FOLLOWING IMPLANT TO CONFIRM EXCLUSION OF THE ANEURYSM. CONSIDER USE OF GORE EXCLUDER AAA ENDOPROSTHESIS EXTENDER COMPONENTS AS NECESSARY.

    Description of Event or Problem · 1

    IN 2008, THIS PT WAS IMPLANTED WITH A GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN INFRARENAL ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL IMPLANTATION SITE HAD A 90 DEGREE ANGLE, AND THE TORTUOUS AORTIC ANATOMY PREVENTED THE TRUNK-IPSILATERAL LEG COMPONENT FROM SEALING. THE LACK OF SEAL WAS NOT APPARENT DURING SURGERY, BECAUSE OF POOR FLUOROSCOPIC IMAGE QUALITY. AN IMAGING REVIEW LATER THAT DAY IDENTIFIED A PROXIMAL TYPE I ENDOLEAK. AT AN UNK DATE THE PHYSICIAN PERFORMED A HYBRID OPEN CONVERSION TO ADDRESS THE ENDOLEAK. THE PHYSICIAN PERFORMED AN EXTERNAL BANDING OF THE AORTA WITH SURGICAL TAPE TO TREAT THE PROXIMAL TYPE I ENDOLEAK. AS AT ABOUT TWO WEEKS POST-PROCEDURE, THE PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS NONE MIH W.L. GORE & ASSOCIATES WLG325 06065159

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention