BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 2745236 · Received September 14, 2012

    Report

    Report Number
    2953200-2012-01783
    Event Type
    Death
    Date Received
    September 14, 2012
    Date of Event
    August 20, 2012
    Report Date
    August 22, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (DEATH, RUPTURE), (CAUSE IS UNKNOWN). 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 AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 17 MONTHS AGO. ANEURYSM SIZE AND MORPHOLOGY ARE UNKNOWN. IT WAS REPORTED THAT THE PATIENT HAD A THORACIC STENT GRAFT IMPLANTED APPROXIMATELY ONE YEAR AGO. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH CHEST PAIN AND A RUPTURED THORACO-ABDOMINAL ANEURYSM RUPTURE. ATTEMPTS TO SAVE THE PATIENT'S LIFE WERE MADE; HOWEVER, THE PATIENT EXPIRED. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEVIED FOR THIS CASE. THE THORACIC STENT GRAFT IS ANOTHER MANUFACTURER'S SENT GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00821322

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Death