BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 1630502 · Received March 11, 2010

    Report

    Report Number
    2953200-2010-00413
    Event Type
    Injury
    Date Received
    March 11, 2010
    Date of Event
    February 11, 2010
    Report Date
    February 11, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4) ( REQUIRED INTERVENTION). EVAL RESULTS: (ENDOLEAK), (REPOSITIONING OF THE STENT GRAFT AFTER IT WAS PARTIALLY DEPLOYED).

    Description of Event or Problem · 1

    A TALENT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM WHICH WAS BETWEEN THE LEFT SUBCLAVIAN AND THE CELIAC ARTERIES. THE AORTA HAD MINIMAL ANGULATION. THERE WERE NO ISSUES NOTED DURING DEVICE PREPPING PRIOR TO THE PROCEDURE. IVUS WAS USED THROUGHOUT THE CASE AND A PORTABLE C-ARM WAS USED IN THE OPERATING ROOM WHICH DID NOT PROVIDE AS CLEAN AN IMAGE AS A STATIONARY C-ARM. IT WAS REPORTED THAT THE FIRST STENT GRAFT WAS IMPLANTED DISTAL TO THE LEFT SUBCLAVIAN ARTERY FOLLOWED BY A SECOND DEVICE; HOWEVER, IT WAS NOTED THAT AS THE PROXIMAL END WAS BEGINNING TO DEPLOY THAT THE STENT GRAFT MIGHT BE CLOSER TO THE CELIAC THAN DESIRED, EVENT THOUGH IT WOULD NOT HAVE COVERED IT. THE PHYSICIAN DECIDED TO REPOSITION THE STENT GRAFT PROXIMALLY ABOUT 5 MM, AND THERE WAS 50% OVERLAP BETWEEN THE 2 STENT GRAFTS. NORMAL/NON-AGGRESSIVE BALLOONING WAS PERFORMED WITH A RELIANT BALLOON. DURING THE FINAL ANGIOGRAM RUN, A TYPE 3 ENDOLEAK (FABRIC/PUNCTURE) WAS PRESENT FROM THE PROXIMAL GRAFT BELOW THE SECOND STENT RING (SEE MFR 2952300-2010-00412). AN ADDITIONAL STENT WAS IMPLANTED TO RELINE THE PROXIMAL GRAFT PORTION AT THE LOCATION OF THE ENDOLEAK AND SUCCESSFULLY RESOLVED THE ENDOLEAK. IT IS LIKELY THAT THE REPOSITIONING OF THE SECOND STENT GRAFT WITHIN THE PROXIMAL DEVICE MAY HAVE CONTRIBUTED TO THE EVENT AS WELL THE IVUS CATHETER MAY HAVE BEEN A FACTOR IN THE EVENT. THERE IS NO EVIDENCE THAT WIRES/BALLOONING CONTRIBUTED TO THE EVENT. 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 V00421675

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention