BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT STENT GRAFT SYSTEM

    MDR report key: 2770966 · Received October 3, 2012

    Report

    Report Number
    2953200-2012-01902
    Event Type
    Death
    Date Received
    October 3, 2012
    Date of Event
    March 16, 2010
    Report Date
    September 7, 2012
    Manufacturer
    MEDTRONIC IRELAND
    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

    RESULTS: INHERENT RISK OF PROCEDURE (DEATH). CONCLUSION: CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.4 CM IN DIAMETER FUSIFORM ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 30 MONTHS AGO. PROXIMAL AORTA WAS 23-25 MM IN DIAMETER AND 14 MM IN LENGTH. DISTAL AORTA WAS 20 MM IN DIAMETER. RIGHT ILIAC ARTERY WAS 13-12-15 MM IN DIAMETER AND THE LEFT ILIAC ARTERY WAS 14-13 MM IN DIAMETER. THE RIGHT AND LEFT FEMORAL ARTERIES WERE 8 MM IN DIAMETER. THE RIGHT AND LEFT ILIAC ARTERIES WERE MILDLY TORTUOUS WITH 10% STENOSIS. THE CIRCUMFERENTIAL AORTIC MURAL THROMBUS/CALCIFICATION AT THE PROXIMAL NECK WAS 5%. IT WAS REPORTED THAT THE PATIENT EXPERIENCE POST-PROCEDURAL BLEEDING OF LESS THAN 1000 CC. THIS EVENT WAS FOUND TO BE RELATED TO THE STUDY PROCEDURE BUT NOT THE STUDY DEVICE. ONE MONTH POST INDEX PROCEDURE, AN ULTRASOUND SHOWED THAT THE ANEURYSM HAD EXPANDED TO 6.3 CM. NO ENDOLEAKS WERE OBSERVED. NO INTERVENTION WAS PERFORMED AND THE CAUSE OF THE EXPANSION IS UNKNOWN. IT WAS REPORTED THAT 16 MONTHS POST INDEX PROCEDURE, THE PATIENT EXPIRED. THE CAUSE OF DEATH IS UNKNOWN. IT IS UNKNOWN IF THIS EVENT WAS RELATED TO THE STUDY DEVICE OR STUDY PROCEDURE PER THE INVESTIGATOR. THE PATIENT WAS HOME AND WAS FOUND TO HAVE HAD A HEAD WOUND. NO AUTOPSY WAS PERFORMED AND NO DEATH REPORT IS AVAILABLE. THE INVESTIGATOR ASSESSED THIS EVENT TO NOT BE DEVICE OR PROCEDURE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00453726

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Death