BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT

    MDR report key: 3092110 · Received May 3, 2013

    Report

    Report Number
    2953200-2013-00819
    Event Type
    Death
    Date Received
    May 3, 2013
    Report Date
    April 10, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION CODES, RESULTS AND CONCLUSIONS: INHERENT RISK OF PROCEDURE (DEATH).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A SACCULAR 97 MM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE PATIENT WAS DISCHARGED NINE DAYS POST IMPLANT AND THE ANEURYSM WAS STILL 97 MM IN DIAMETER. NO COMPLICATIONS WERE REPORTED SINCE THE TIME OF IMPLANT. SEVEN MONTHS POST IMPLANT, THE ANEURYSM WAS 89 MM IN DIAMETER. AT 14 MONTHS POST IMPLANT, THE ANEURYSM WAS 85 MM IN DIAMETER. AN ULTRASOUND AT 29 MONTHS POST IMPLANT SHOWED THE ANEURYSM WAS 72 MM IN DIAMETER. IT WAS RECENTLY REPORTED THAT THE PATIENT IS NOW DECEASED. NO ADVERSE EVENT WAS REPORTED. THE DATE AND CAUSE OF DEATH ARE UNKNOWN. THE EVENT RELATIONSHIP TO THE STUDY PROCEDURE AND THE STUDY DEVICE ARE UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    UPDATED INFORMATION WAS RECEIVED. THE PATIENT EXPIRED DUE TO MALIGNANT DYSRHYTHMIA. NO AUTOPSY WAS PERFORMED. THE PHYSICIAN ASSESSED THIS EVENT AS NOT DEVICE OR PROCEDURE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194093 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA V00237060

    Patients

    Seq Age Sex Outcome Treatment
    1 Death