BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 1850892 · Received September 28, 2010

    Report

    Report Number
    2953200-2010-01835
    Event Type
    Injury
    Date Received
    September 28, 2010
    Date of Event
    August 30, 2010
    Report Date
    August 30, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: TIGHT BEND BOVINE ARCH, TREATMENT OF A DISSECTION ANEURYSM IN A TIGHTLY BENT BOVINE ARCH. CONCLUSIONS: TIGHT BEND BOVINE ARCH, TREATMENT OF A DISSECTION ANEURYSM IN A TIGHTLY BENT BOVINE ARCH.

    Description of Event or Problem · 1

    A TALENT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM LOCATED IN THE FALSE LUMEN OF A THORACIC DISSECTION. THE ANEURYSM HAS EXPANDED FROM 4.7 CM TO 5.9 CM IN ONE YEAR. THE PATIENT HAS A TIGHT BEND OF THE BOVINE ARCH. THERE WAS A CAROTID TO SUBCLAVIAN BYPASS IN PREPARATION FOR THE STENT GRAFT IMPLANT. THE STENT GRAFT DEPLOYMENT WAS STARTED IN THE ASCENDING ARCH; HOWEVER, THE APEX OF THE FIRST STENT GRAFT STARTED UP MISALIGN. THE PHYSICIAN WAS ABLE TO PULL THE DEVICE BACK TO THE INTENDED DISTAL LANDING ZONE AND SUCCESSFULLY CORRECTED THE MISALIGNMENT. THE DECISION WAS MADE TO BACK BUILD THE STENT GRAFTS AND A SECOND STENT GRAFT WAS IMPLANTED DISTALLY WITHOUT COMPLICATION. A THIRD STENT GRAFT WAS ADVANCED TO THE SAME LOCATION AS THE FIRST STENT GRAFT, AND UPON DEPLOYMENT, THE STENT GRAFT APEX MISALIGNED. THE DEVICE WAS PULLED BACK, BUT THERE WAS NOT ENOUGH ROOM DISTALLY, THEREFORE, IT WAS NOT POSSIBLE TO CORRECT THE MISALIGNMENT AND THE APEX REMAINED SLIGHTLY MISALIGNED (SEE MFR # 2953200-2010-1836). THE PHYSICIAN CHANGED FROM A LUNDERQUIST WIRE TO AN AMPLATZ WIRE AND ADMINISTERED A HIGHER DOSE OF ADENOSINE. A FOURTH DEVICE WAS DEPLOYED SUCCESSFULLY. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA NA V00174783

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention