BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 1983032 · Received February 7, 2011

    Report

    Report Number
    2953200-2011-00302
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    January 8, 2011
    Report Date
    January 8, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (ENDOLEAK, INACCURATE PLACEMENT); (ACCESS VESSELS WERE NARROW IN DIAMETER); (CONDUIT); (STENT GRAFT WAS IMPLANTED FOR THE TREATMENT OF A PRE-OPERATIVELY RUPTURED ANEURYSM). CONCLUSION: (ACCESS VESSELS WERE NARROW IN DIAMETER); (CONDUIT); (STENT GRAFT WAS IMPLANTED FOR THE TREATMENT OF A PRE-OPERATIVELY RUPTURED ANEURYSM).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF A 7 CM RUPTURED THORACIC AORTIC ANEURYSM (EXTENDING FROM THE LEFT SUBCLAVIAN TO THE CELIAC ARTERY) APPROX 1 MONTH AGO. THE AORTIC ARCH HAD MODERATE ANGULATION/TORTUOSITY, AND THE THORACIC AORTIC NECK WAS ABOUT 31-32 MM IN DIAMETER. THE ILIAC VESSELS WERE SMALL IN DIAMETER, 6MM. IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO ADVANCE THE FIRST PROXIMAL MAIN DELIVERY CATHETER THROUGH THE ILIAC ARTERIES AS THE DIAMETER WAS VERY NARROW IN DIAMETER. THE DEVICE WAS REMOVED, AND THERE WAS NO KINKING NOTED. THE PHYSICIAN INSERTED CONDUIT DIRECTLY TO THE DISTAL AORTA. THE FIRST PROXIMAL MAIN GRAFT WAS IMPLANTED WITHOUT ISSUES THROUGH THE CONDUIT. THEN, A DISTAL MAIN GRAFT DEVICE WAS DELIVERED, AND THERE WAS SOME FRICTION FROM THE VESSEL LOOPS USED TO SECURE THE CONDUIT WITH THE DELIVERY SYSTEM. AS A RESULT, DURING DEPLOYMENT, THE DISTAL MAIN STENT GRAFT WAS MOVED PROXIMAL UNINTENTIONALLY. (REF. MFR# 2953200-2011-00303) AN ATTEMPT WAS MADE TO PULL THE DELIVERY SYSTEM AND DEPLOYING DISTAL MAIN GRAFT DOWNWARD SLIGHTLY, WHICH IN TURN, CAUGHT ONTO AND PULLED DOWN THE PROXIMAL PIECE UNINTENTIONALLY ABOUT 1 CM. THE DISTAL MAIN ENDED UP EXTENDING ONLY 10-15 MM DISTAL FROM THE PROXIMAL PIECE, WHICH WAS NOT ENOUGH OF AN EXTENSION AS PLANNED. TWO ADDITIONAL DISTAL PIECES WERE PLACED TO CONTINUE TO BUILD DISTALLY IN A PLANNED FASHION. DURING THE FINAL ANGIOGRAM, A SLIGHT PROXIMAL TYPE I ENDOLEAK WAS EVIDENT. A 36 MM TALENT PROXIMAL EXTENSION WAS PLACED PROXIMALLY TO RESOLVE THE ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00515176

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention