BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC ANEURX BIFURCATED STENT GRAFT

    MDR report key: 631816 · Received April 21, 2005

    Report

    Report Number
    2953200-2005-01257
    Event Type
    Injury
    Date Received
    April 21, 2005
    Date of Event
    March 1, 2004
    Report Date
    April 21, 2004
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    MIH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 26 MM DIAMETER X 15 MM DIAMETER X 16.5 CM LENGTH ANEURX BIFURCATED STENT GRAFT AND ITS COMPONENTS WERE IMPLANTED IN PATIENT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THIS STENT GRAFT WAS ORIGINALLY IMPLANTED UNDER THE CLINICAL STUDY, G-960016, PER THIS CLINICAL STUDY'S APPROVED CLINICAL PROTOCOL, PATIENT FOLLOW-UP UNDER THIS STUDY TERMINATES AFTER THE PATIENT'S FIVE YEAR FOLLOW-UP VISIT. SINCE THE PATIENT WITH THIS STENT GRAFT IS PAST THEIR FIVE-YEAR FOLLOW-UP VISIT, THE FOLLOWING PATIENT INFORMATION IS BEING COMMUNICATED TO FDA VIA THE MEDWATCH PROCESS. ANEURYSM DIAMETER WAS 7.8 CM WITH SEVERE PROXIMAL AORTIC NECK ANGULATION. THE INITIAL RESULT WAS REPORTED TO BE EXCELLENT WITH AAA EXCLUSION DESPITE THE PATIENT'S CHALLENGING ANATOMY. THE PATIENT WAS A POOR CANDIDATE FOR OPEN SURGICAL REPAIR DUE FRAILTY REPAIR AND ADVANCED AGE MADE PT A POOR CANDIDATE FOR OPEN SURGICAL REPAIR. THE AORTIC NECK WAS REPORTED TO BE 26 MM IN DIAMETER WITH A 90-DEGREE ANGLE. 33 MONTHS AFTER THE ANEURX STENT GRAFT IMPLANTATION THE PT UNDERWENT IMPLANTATION OF A TALENT ENDOGRAFT UNDER TALENT AORTIC CUFF TRIAL (IDE-G020050). ANOTHER TALENT CUFF WAS REQUESTED AFTER AN ADDITIONAL 33 MONTHS ALSO UNDER TALENT CUFF TRIAL (IDE-G020050). NO ADD'L CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC ANEURX BIFURCATED STENT GRAFT AAA STENT GRAFT MIH MEDTRONIC VASCULAR NA M9811137

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention