BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2872667 · Received December 13, 2012

    Report

    Report Number
    2953200-2012-02424
    Event Type
    Death
    Date Received
    December 13, 2012
    Date of Event
    November 9, 2012
    Report Date
    December 14, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (DEATH, ENDOLEAK ). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (DEATH DUE TO HEART RELATED COMPLICATIONS). EVALUATION CODES, CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (DEATH DUE TO HEART RELATED COMPLICATIONS).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY ONE MONTH AGO. ANEURYSM AND VESSEL MORPHOLOGY ARE UNKNOWN. A TOTAL OF 5 STENT GRAFTS WERE SUCCESSFULLY IMPLANTED AND THE DELIVERY SYSTEMS WERE DISCARDED. IT WAS REPORTED THAT AT THE FINAL ANGIOGRAM, THE PHYSICIAN DISCOVERED AN UNKNOWN ENDOLEAK. IT WAS REPORTED THAT THE PATIENT EXPIRED 13 DAYS POST IMPLANT DUE TO A HEART RELATED COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: IT IS UNKNOWN IF THE ENDOLEAK RESOLVED. A FOLLOW UP CT COULD NOT BE PERFORMED DUE TO PATIENT CONDITION. AT IMPLANT, THERE WAS AN ABDOMINAL AORTIC ANEURYSM WITH A ARTERIOVENOUS FISTULA BETWEEN THE ANEURYSM AND LEFT COMMON ILIAC VEIN. THE PATIENT EXPIRED DUE TO A MYOCARDIAL INFARCTION OF RIGHT CORONARY ARTERY (RIGHT HEART FAILURE). IT WAS ALSO REPORTED THAT 4000 UNITS OF HEPARIN WERE USED DURING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01120393

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Death