BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT II STENT GRAFT SYSTEM

    MDR report key: 2830287 · Received November 13, 2012

    Report

    Report Number
    2953200-2012-02175
    Event Type
    Death
    Date Received
    November 13, 2012
    Date of Event
    October 20, 2012
    Report Date
    October 20, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (DEATH); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (PRE-OPERATIVE RUPTURE); INCORRECT TECHNIQUE/PROCEDURE (TREATMENT OF A PRE-OPERATIVELY RUPTURED ANEURYSM). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (PRE-OPERATIVE RUPTURE); OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (TREATMENT OF A PRE-OPERATIVELY RUPTURED ANEURYSM).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF A PRE-OPERATIVE CONTAINED RUPTURE OF THE RIGHT INTERNAL ILIAC ARTERY ANEURYSM, AN INFRA-RENAL ABDOMINAL AORTIC ANEURYSM, A LEFT RENAL ARTERY ANEURYSM, AND OCCLUSION OF THE BRANCH VESSELS FROM THE RIGHT SIDE. THE OPERATIVE REPORT STATED THAT THE PATIENT HAD PREVIOUSLY PRESENTED WITH VERY COMPLEX CLINICAL PROBLEMS. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY, THE PHYSICIAN WAS PERFORMING THE CUT-DOWNS, AND THE PATIENT'S RIGHT INTERNAL ANEURYSM COMPLETELY RUPTURED AND THE PATIENT LOST PULSE. THE PHYSICIAN INFLATED AN OCCLUSION BALLOON ABOVE THE RENAL ARTERY TO KEEP THE PATIENT ALIVE. THE STENT GRAFTS WERE SUCCESSFULLY IMPLANTED AND THE PATIENT WAS SENT TO RECOVERY. IT WAS REPORTED THAT THE FOLLOWING DAY THE PATIENT HAD AN ATHEROEMBOLI INTO THE SMA AND WAS REMOVED FROM LIFE SUPPORT. THE PATIENT EXPIRED THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT II STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01138211

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Death