BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 1222054 · Received November 6, 2008

    Report

    Report Number
    2953200-2008-01014
    Event Type
    Injury
    Date Received
    November 6, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 8, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: TYPE B DISSECTION. UNAPPROVED USE OF DEVICE, DEVICE IS INDICATED FOR TREATMENT OF ANEURYSMS. OTHER, PENDING FILM EVALUATION. SECONDARY INTERVENTION. MISALIGNED DEPLOYMENT.

    Description of Event or Problem · 1

    A TALENT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A DISSECTED THORACIC AORTA. THE LESSER CURVE WAS ACUTE AT 90 DEGREES. THE OUTER CURVATURE WAS NOT ACUTE. THE PATIENT WAS TREATED FOR A DISSECTED THORACIC AORTA. THE MEAN BLOOD PRESSURE WAS REDUCED TO 55 AND WHEN THE STENT GRAFT WAS DEPLOYED, IT WAS MISALIGNED (MDR2953200-2008-01013). THE PHYSICIAN FOLLOWED THE IFU DEPLOYMENT TECHNIQUE AND PULLED THE STENT GRAFT DOWN 3 - 4 CM; HOWEVER, THE STENT GRAFT DID NOT STRAIGHTEN. DEPLOYMENT OF THE STENT GRAFT WAS COMPLETED IN THE MISALIGNED POSITION. THE STENT GRAFT ENDED UP DISTAL TO THE DESIRED POSITION. THE MEAN BLOOD PRESSURE WAS RESTORED. THE PHYSICIAN ELECTED TO PLACE ANOTHER TALENT THORACIC STENT GRAFT. PRIOR TO DEPLOYMENT, THE MEAN BLOOD PRESSURE WAS REDUCED TO 55. THIS TIME DEPLOYMENT WAS INITIATED MORE PROXIMAL AND THE SAME THING HAPPENED, THE STENT GRAFT DEPLOYED MISALIGNED. AGAIN THE PHYSICIAN FOLLOWED THE IFU DEPLOYMENT TECHNIQUE AND PULLED THE STENT GRAFT MORE DISTALLY, BUT IT REMAINED IN THE MISALIGNED POSITION. THERE WAS A TYPE 1 ENDOLEAK BUT NOT FROM THE MISALIGNED STENT GRAFT BUT FROM THE DISSECTION. THE DECISION WAS MADE TO NOT FURTHER INTERVENE. AT 1 MONTH CT WILL BE PERFORMED TO DECIDE HOW TO PROCEED. FILMS HAVE BEEN RECEIVED AND SENT TO A CONSULTANT FOR REVIEW. NO ADDITIONAL 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 NA V00177806

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention