BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM - XCELERANT

    MDR report key: 1734602 · Received June 22, 2010

    Report

    Report Number
    2953200-2010-01186
    Event Type
    Death
    Date Received
    June 22, 2010
    Date of Event
    May 24, 2010
    Report Date
    May 24, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). EVAL RESULTS: DEATH; ANGULATED AND DISEASED AORTA. CONCLUSION: ANGULATED AND DISEASED AORTA.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT DEVICE WAS IMPLANTED INTO A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5CM THORACIC AORTIC ANEURYSM. THE AORTA WAS ANGULATED WITH AN 80 DEGREE BEND AND THEN A 60 DEGREE BEND OF THE DESCENDING THORACIC AORTA TOWARD THE CELIAC ARTERY. THE ILIAC ARTERIES WERE SEVERELY TORTUOUS. THE PATIENT HAD A PREVIOUS AORTO-BI-FEMORAL BYPASS FOR AN AAA REPAIR ON 4 MONTHS AGO. FOUR TALENT THORACIC STENT GRAFTS WERE IMPLANTED 1 MONTH AGO USING A CONDUIT IN ORDER TO AVOID INSERTION THROUGH THE AORTO-BI-FEMORAL BYPASS GRAFT. THE PROXIMAL-MOST DEVICE WAS IMPLANTED IN A STRAIGHT AREA OF THE AORTIC ARCH; HOWEVER, DUE TO THE DISTAL AORTIC ANGULATION, THERE WAS DIFFICULTY REMOVING THE REMAINING 3 DELIVERY SYSTEM AFTER THE STENT GRAFTS WERE IMPLANTED AS THE NOSE CONES WERE CATCHING ON THE AORTIC CURVES. FOR THE SECOND DEVICE FROM THE PROXIMAL END THE PHYSICIAN ADVANCED A SHEATH TO CONSTRAIN THE NOSE CONE AND RECAPTURE IT SUCCESSFULLY (SEE MFR # 2953200-2010-01184). THE NOSE CONES OF THE THIRD AND FOURTH DEVICES WERE RECAPTURED BY USING A RELIANT BALLOON TO DEFLECT THE NOSE CONE AWAY FROM THE AORTIC CURVES (SEE MFR #2953200-2010-01185). ALL 3 DEVICES WERE SUCCESSFULLY REMOVED WITH THE NOSE CONES RECAPTURED. THE PATIENT WAS STABLE POST-OPERATIVELY. HOWEVER, THE PATIENT WENT INTO MULTI-ORGAN FAILURE AND EXPIRED THE NEXT DAY POST-OPERATIVELY FROM A MASSIVE ATHEROEMBOLI, WHICH PRESUMABLY CAME DURING THE ENDOVASCULAR REPAIR. THE PATIENT DEVELOPED MULTISYSTEM DYSFUNCTION PRESUMABLY FROM SHOWER EMBOLI DURING ENDOVASCULAR REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM - XCELERANT MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00439891

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death