BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT CAPTIVIA STENT GRAFT

    MDR report key: 2167199 · Received July 13, 2011

    Report

    Report Number
    2953200-2011-01270
    Event Type
    Death
    Date Received
    July 13, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 17, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS AND CONCLUSION: (DEATH, RUPTURED VESSEL), (IMPLANTING A DEVICE FOR A PRE-OPERATIVE RUPTURE).

    Description of Event or Problem · 1

    FIVE TALENT THORACIC STENT GRAFTS WERE IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A THORACIC ANEURYSM APPROX 27 MONTHS AGO. IT WAS REPORTED THAT THE PT PRESENTED EMERGENTLY WITH A CONTAINED RUPTURED ANEURYSM DUE TO A DISTAL TYPE 1 ENDOLEAK THAT WAS PRESSURIZING THE ANEURYSM SAC. THE DECISION WAS MADE TO RELINE THE PREVIOUS STENT GRAFTS WITH TWO TALENT CAPTIVIA STENT GRAFTS. IT WAS REPORTED THAT THE FIRST STENT GRAFT WAS SUCCESSFULLY DEPLOYED W/O COMPLICATION (REF MFR # 2953200-2011-01270). THE SECOND STENT GRAFT WAS FULLY DEPLOYED WHEN THE STENT GRAFT SLIPPED DOWN AND COVERED THE CELIAC, SMA AND BOTH RENAL ARTERIES. (REF. MFR. # 2953200-2011-01271) THE PHYSICIAN HAD PUSHED THE GRAY TO BLUE HANDLE W/O UNLOCKING / RELEASING THE PROXIMAL BARE SPRINGS. THE BLOOD PRESSURE RUPTURED THE ANEURYSM AS THE BLOOD COULD NOT PASS THROUGH AND THE PT CONSEQUENTLY EXPIRED. (REF. MFR. #S 2953200-2011-01272; 2953200-2011-01273; 2953200-2011-01274; 2953200-2011-01275; 2953200-2011-01276).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT CAPTIVIA STENT GRAFT MIH MEDTRONIC CARDIOVASCULAR IRELAND NA V00842431

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death