BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 2031693 · Received March 18, 2011

    Report

    Report Number
    2953200-2011-00674
    Event Type
    Death
    Date Received
    March 18, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL, RESULTS: (DEATH, VESSEL PERFORATION). (SIX TO SEVEN MM IN DIAMETER EXTERNAL ILIAC ARTERIES WITH MODERATE CALCIFICATION). (OTHER MFR'S BALLOON MAY HAVE CONTRIBUTED). EVAL CODES, CONCLUSION: (SIX TO SEVEN MM IN DIAMETER EXTERNAL ILIAC ARTERIES WITH MODERATE CALCIFICATION). (OTHER MFR'S BALLOON MAY HAVE CONTRIBUTED).

    Description of Event or Problem · 1

    A TALENT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A SACCULAR THORACIC ANEURYSM OF ZONE 2. THE PROXIMAL NECK IS 31 MM AND THE DISTAL NECK IS 28-29MM. THE EXTERNAL ILIAC ARTERIES WERE APPROX 6 TO 7 MM IN DIAMETER WITH MODERATE CALCIFICATION BUT NO THROMBUS, AND THE AORTA HAD A MODERATE BEND. IT WAS REPORTED THAT A TALENT THORACIC DELIVERY SYSTEM WAS ATTEMPTED TO BE INSERTED FROM BOTH SIDES; HOWEVER, THE DELIVERY SYSTEM COULD NOT BE ADVANCED FROM THE FEMORAL ARTERY TO THE EXTERNAL ILIAC ARTERY. BOTH ILIAC ARTERIES WERE BALLOONED; HOWEVER, THEN THE BLOOD PRESSURE DROPPED, AS BLEEDING FROM BOTH ILIAC ARTERIES WAS OBSERVED. THE PHYSICIAN ELECTED TO SURGICALLY REPAIR THE ILIAC ARTERIES, WHICH INCLUDED REPLACING THE RIGHT ILIAC ARTERY WITH A SYNTHETIC GRAFT. DURING THE SURGICAL REPAIR, AS THE BLOOD PRESSURE KEPT FLUCTUATING AND ILIAC HEMORRHAGING CONTINUED, BLOOD TRANSFUSIONS AND CELL SAVER WERE USED; HOWEVER, THE PT EXPIRED DURING THE SURGICAL REPAIR. NO AUTOPSY WAS PERFORMED, AND THE EXACT CAUSE OF DEATH IS UNK. THE PHYSICIAN COMMENTED THAT THE ILIAC INJURY WAS CAUSED BY BALLOONING THE VESSEL AT A CALCIFIED AREA BEFORE THE SECOND INSERTION ATTEMPT OF THE TALENT DELIVERY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR IRELAND NA V00548030

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death