BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT

    MDR report key: 4122373 · Received September 26, 2014

    Report

    Report Number
    2953200-2014-01943
    Event Type
    Death
    Date Received
    September 26, 2014
    Date of Event
    September 1, 2010
    Report Date
    April 23, 2015
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FOR THIS CASE. THE INVESTIGATOR REPORTED THE CAUSE OF DEATH WAS NOT DEVICE OR PROCEDURE RELATED. THERE IS NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 1

    (B)(4)

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. THE INVESTIGATOR REPORTED THAT THE PATIENT EXPIRED, HOWEVER THE CAUSE WAS NOT REPORTED. THERE IS NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601254 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA V00235366

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Death