BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2276708 · Received September 30, 2011

    Report

    Report Number
    2953200-2011-01695
    Event Type
    Injury
    Date Received
    September 30, 2011
    Date of Event
    September 1, 2011
    Report Date
    September 1, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (ENDOLEAK). RESULTS AND CONCLUSION: (ANATOMY RELATED; SHORT AND ANGULATED AORTIC NECK). (SHORT AND ANGULATED AORTIC NECK).

    Additional Manufacturer Narrative · 1

    MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A ABDOMINAL AORTIC ANEURYSM. AAA DIAMETER IS UNK. AORTIC NECK WAS CHALLENGING AS IT WAS HAD A FIGURE 8-SHAPE WITH A DIAMETER GOING FROM 26-24-32MM, WAS 12 MM LONG, AND HAD A 90 DEGREE TURN. OTHER VESSEL MORPHOLOGY WAS UNREMARKABLE. THERE WAS A PROXIMAL TYPE IN ENDOLEAK, DUE TO THE SHORT AND ANGULATED AORTIC NECK, POST IMPLANT. THE PHYSICIAN BALLOONED THE STENT GRAFT, WHICH IMPROVED THE ENDOLEAK SOMEWHAT. THE PT CONTINUES TO BE MONITORED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY ENBF3216C145E V00859899

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR