BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 2031356 · Received March 23, 2011

    Report

    Report Number
    2953200-2011-00685
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (DISSECTION), (PRIOR DISSECTION), (EXISTING SYNTHETIC GRAFT). CONCLUSIONS: (PRIOR DISSECTION).

    Description of Event or Problem · 1

    A TALENT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A SACCULAR ANEURYSM WITH A DIAMETER OF 50 MM AND A LENGTH OF 26 MM, AT ZONE 4 AND CHRONIC TYPE B DISSECTION, APPROX 1 MONTH AGO. THE PT PREVIOUSLY HAD A SYNTHETIC GRAFT PLACED IN THE THORACIC AORTA, WHICH WAS THEN REPLACED DUE TO A CHRONIC TYPE B DISSECTION. THE PROXIMAL THORACIC NECK DIAMETER WAS 30 MM WITH A DISTAL THORACIC NECK DIAMETER OF 22MM. A TALENT TF2626 WAS SUCCESSFULLY IMPLANTED IN THE DISTAL SECTION OF THE TAA. IT WAS REPORTED THAT DURING THE DEPLOYMENT OF THE TALENT TW3228 IN THE PROXIMAL PORTION OF THE TAA, THE COVERED APEX OF THE STENT GRAFT WAS DEPLOYED MISALIGNED RESULTING IN A TYPE I ENDOLEAK. A TALENT TAXF3232 WAS THEN IMPLANTED PROXIMALLY, TO TREAT THE TYPE I ENDOLEAK, HOWEVER THE TYPE I ENDOLEAK WAS NOT RESOLVED. (REF MFR 2953200-2011-00686). THE PHYSICIAN MODELED THE STENT GRAFT WITH A BALLOON SEVERAL TIMES, HOWEVER, WAS UNABLE TO RESOLVE THE ENDOLEAK. THE PHYSICIAN DECIDED TO MONITOR THE PT W/O ANY ADD'L TREATMENT AND THUS COMPLETED THE PROCEDURE. IT WAS REPORTED THAT TWO DAYS LATER THE PT COMPLAINED OF BACK PAIN. A CT PERFORMED THE FOLLOWING DAY SHOWED A TYPE B DISSECTION AT THE DISTAL SIDE OF THE SYNTHETIC GRAFT, AND AN ANEURYSM DIAMETER OF 52 MM, W/O ANEURYSM RUPTURE OR STENT GRAFT MIGRATION. AS THERE WAS A POSSIBILITY OF RUPTURE DUE TO THE CONTINUOUS BACK PAIN, THE PHYSICIAN IMPLANTED TWO STENT GRAFTS (TF2424, TF3030) OVERLAPPING THE PREVIOUS THORACIC STENT GRAFT AND COVERING THE DISSECTION. (REF MFR 2953200-2011-00687). THE PHYSICIAN ASSESSED THAT THE TYPE IA ENDOLEAK HAD NO RELATION TO THE TALENT STENT GRAFT, BUT WAS RELATED TO THE PROCEDURE. THE PHYSICIAN ALSO DETERMINED THAT THE TYPE B DISSECTION, AT THE DISTAL SIDE OF THE SYNTHETIC GRAFT, MAY HAVE BEEN CAUSED BY THE REPEATED MODELING WITH A BALLOON TO RESOLVE THE ENDOLEAK. THE PHYSICIAN BELIEVES THAT THE DISSECTION IS RELATED TO THE PROCEDURE. NO CLINICAL SEQUELAE WERE REPORTED AND THE PT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC IRELAND NA V00795179

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention