BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

    MDR report key: 2091689 · Received April 29, 2011

    Report

    Report Number
    2953200-2011-00913
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    March 31, 2011
    Report Date
    March 31, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS, CONCLUSION: (DILATED AORTIC NECK).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROX TWO YRS AGO. THE TALENT BIFURCATED STENT GRAFT WAS ORIGINALLY DEPLOYED ONE CM BELOW THE LEVEL OF THE RENAL ARTERIES. THE NATIVE AORTIC NECK WAS 26.5 MM IN DIAMETER AND THERE WAS A PROXIMAL TYPE I ENDOLEAK AND NO INTERVENTION WAS DONE AT THE TIME. IT WAS REPORTED THAT THE PT PRESENTED EMERGENTLY APPROX ONE MONTH AGO. A CT SCAN WAS PERFORMED AND DEMONSTRATED THAT THE TALENT BIFURCATED STENT GRAFT HAS MIGRATED 4 CM FROM THE RENAL ARTERY WITH A TYPE I ENDOLEAK PRESENT (REF MFR # 2953200-2011-00912). CURRENTLY AT THE RENAL ARTERIES THE NATIVE AORTA MEASURED 33 MM IN DIAMETER, 34 MM IN DIAMETER AND 36 MM IN DIAMETER, USING 5MM SLICES. A 36 MM DIAMETER TALENT AORTIC CUFF WAS IMPLANTED; HOWEVER, IT WAS NOT LONG ENOUGH; THEREFORE, THE DECISION WAS MADE TO IMPLANT A TALENT THORACIC CAPTIVIA. PRIOR TO INSERTION OF THE TALENT THORACIC CAPTIVIA THE STENT GRAFT WAS DEPLOYED ON THE BACK TABLE. THE PHYSICIAN CUT THE STENT GRAFT TO THE DESIRED LENGTH AND CREATED A FENESTRATION IN THE STENT GRAFT THEN RE-LOADED IT INTO THE DELIVERY CATHETER AND SUCCESSFULLY IMPLANTED IT IN THE PT. NO ADD'L CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention