BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT II

    MDR report key: 3815819 · Received May 16, 2014

    Report

    Report Number
    2953200-2014-01011
    Event Type
    Death
    Date Received
    May 16, 2014
    Date of Event
    May 12, 2014
    Report Date
    June 6, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTS THAT THE PATIENT SUFFERED AN MI. PATIENT HAD A SOFT PLAQUE OCCLUSION OF HER RIGHT CORONARY OSTIA CAUSING MI FORM WHICH CAUSED HER DEATH. THE PHYSICIAN FEELS THAT THE MI WAS UNRELATED TO THE DEVICE OR PROCEDURE.

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 5.0 CM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL AORTIC NECK WAS 18 MM IN DIAMETER, WITH A LENGTH OF 12 MM. THE DISTAL AORTIC NECK WAS 20 MM IN DIAMETER. THE NECK WAS REPORTED TO BE TORTUOUS, BUT NOT OFF-LABEL. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO IMPLANT THE STENT GRAFT. THE DEVICE WAS LANDED BELOW WHERE IT HAD BEEN INTENDED, AND WAS UNABLE TO ACHIEVE AN ADEQUATE SEAL. A CUFF WAS PLACED, AND RESOLVED ALL BUT A SMALL TYPE IA ENDOLEAK. THE PHYSICIAN BELIEVED THAT FURTHER BALLOONING WOULD DO MORE HARM THAN GOOD, AND THAT ANTICOAGULATION MEDICATION WOULD RESOLVE THE ISSUE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED. LATER IT WAS REPORTED THAT THE PATIENT SUFFERED AN MI. THE PHYSICIAN FEELS THAT THE MI WAS UNRELATED TO THE DEVICE OR PROCEDURE. THE PATIENT IS CURRENTLY HOSPITALIZED AND IN AN UNSTABLE CONDITION. RELEVANT MEDICAL HISTORY: SEVERE SCOLIOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294291 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04204128

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Death| R