BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT STENT GRAFT SYSTEM

    MDR report key: 2153059 · Received June 29, 2011

    Report

    Report Number
    2953200-2011-01226
    Event Type
    Death
    Date Received
    June 29, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 3, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: DEATH, PRE-EXISTING RUPTURED ANEURYSM, TREATMENT OF PRE-OPERATIVE RUPTURE. EVALUATION, CONCLUSION: PRE-EXISTING RUPTURED ANEURYSM, TREATMENT OF A PRE-OPERATIVE RUPTURE.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 8 YEARS AGO. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. IT IS UNK HOW THE PT PRESENTED. A RECENT CT DEMONSTRATED THAT THE ANEURX STENT GRAFT (2953200-2011-01224) HAS MIGRATED WITH A TYPE I ENDOLEAK AND THE ANEURYSM HAS RUPTURED. IT WAS REPORTED THAT THE MIGRATION WAS DUE TO AORTIC NECK DILATATION AND AORTIC NECK ELONGATION. THE PHYSICIAN ELECTED TO IMPLANT AN 28 MM ANEURX AORTIC CUFF (2953200-2011-01225) AND A 32 MM ENDURANT AORTIC CUFF (2953200-2011-01226) AND THE MIGRATION AND ENDOLEAK WERE RESOLVED. IT WAS REPORTED THAT TWO DAYS POST-INTERVENTION, THE PT EXPIRED, THE CAUSE TO DEATH WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR IRELAND NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death