BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT STENT GRAFT SYSTEM

    MDR report key: 2801885 · Received October 23, 2012

    Report

    Report Number
    2953200-2012-02015
    Event Type
    Death
    Date Received
    October 23, 2012
    Date of Event
    April 21, 2011
    Report Date
    September 25, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (DEATH, STENOSIS, CARDIAC ARREST, ENDOLEAK); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANATOMY RELATED; TYPE 2 ENDOLEAK). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANATOMY RELATED; TYPE 2 ENDOLEAK).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF A 7 CM IN DIAMETER FUSIFORM ABDOMINAL AORTIC ANEURYSM WAS REPORTED WITH AN INFRARENAL ANGLE OF 30 DEGREES, AND A SUPRARENAL OF 110 DEGREE. THE PROXIMAL AORTA WAS 21 MM IN DIAMETER AND 30 MM IN LENGTH. DISTAL AORTA WAS 30 MM IN DIAMETER. RIGHT ILIAC ARTERY WAS 18 MM IN DIAMETER AND THE LEFT ILIAC ARTERY WAS 14 MM IN DIAMETER. THE RIGHT AND LEFT FEMORAL ARTERIES WERE 9 MM IN DIAMETER. IT WAS REPORTED THAT THREE MONTHS POST INDEX PROCEDURE THE PATIENT HAD LEG PAIN; WHICH RESOLVED. FOUR MONTHS POST INDEX PROCEDURE AN ULTRASOUND CONFIRMED A TYPE II ENDOLEAK, WHICH WAS LEFT UNCORRECTED. THE INVESTIGATOR ASSESSMENT STATES THIS EVENT WAS NOT RELATED TO THE STUDY DEVICE OR STUDY PROCEDURE. TWENTY MONTHS POST INDEX PROCEDURE THE PATIENT WAS DIAGNOSED WITH STENOSIS. THE PATIENT HAD INTERMITTENT CLAUDICATION, THERE WAS NO REVASCULARIZATION OPTION. THE PATIENT WAS TO TRY SUPERVISED EXERCISE THERAPY. THE INVESTIGATOR ASSESSMENT STATES THIS EVENT WAS NOT RELATED TO THE STUDY DEVICE OR STUDY PROCEDURE. THE EVENT WAS UNRESOLVED. IT WAS REPORTED THAT THE PATIENT HAD A CARDIAC ARREST 10 MONTHS AGO; THE PATIENT EXPIRED. THE INVESTIGATOR ASSESSMENT STATES THIS EVENT WAS NOT RELATED TO THE STUDY DEVICE OR STUDY PROCEDURE. AN AUTOPSY WAS NOT PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA V00350219

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Death| H