BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THROACIC STENT GRAFT SYSTEM

    MDR report key: 2013263 · Received March 8, 2011

    Report

    Report Number
    2953200-2011-00612
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    February 3, 2011
    Report Date
    March 24, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    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). EVALUATION, RESULTS: FROM THE INFORMATION PROVIDED THE CAUSE OF THE MISALIGNED OPENINGS CANNOT BE DETERMINED; INACCURATE PLACEMENT; USE FOR PATENT DUCTUS ARTERIOSUS. EVALUATION, CONCLUSIONS: FROM THE INFORMATION PROVIDED THE CAUSE OF THE MISALIGNED OPENINGS CANNOT BE DETERMINED; USE FOR PATENT DUCTUS ARTERIOSUS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: THE 24-MONTH POST-PROCEDURE FOLLOW-UP SHOWED THE MAXIMUM ANEURYSM DIAMETER WAS 42MM WITH NO ISSUES NOTED. THE 36-MONTH POST-PROCEDURE FOLLOW-UP WAS NOT CARRIED OUT SINCE THE PATIENT DID NOT SHOW UP (IT WAS CONFIRMED THAT THE PATIENT WAS ALIVE) WITH NO ISSUES NOTED.

    Description of Event or Problem · 1

    A TALENT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A PATENT DUCTUS ARTERIOSUS (PDA) APPROXIMATELY ONE MONTH AGO. THE LESION IS LOCATED IN ZONE 4. THE PROXIMAL NECK DIAMETER IS 40 MM AND THE DISTAL DIAMETER IS 30 MM. THERE WAS NO THROMBUS AND NO CALCIFICATION. IT WAS REPORTED THAT A TALENT TAA STENT GRAFT WAS INSERTED INTO THE DISTAL PART OF THE PDA. DURING EXPANSION OF THE STENT GRAFT, THE PROXIMAL SPRING (COVERED SPRING) WAS MISALIGNED. THE MISALIGNED SPRING WAS CORRECTED BY WITHDRAWING THE DELIVERY SYSTEM AND THE SPRING CONVERTED TO THE PROPER ALIGNMENT BUT THE IMPLANTED POSITION WAS ONE SPRING DISTAL FROM THE PLANNED POSITION. A SECOND TALENT TAA PROXIMAL MAIN WAS INSERTED INTO THE PROXIMAL LESION AND THE PROXIMAL BARE SPRING WAS MISALIGNED AGAIN (REFERENCE FILE #2953200-2011-00613). BY WITHDRAWING THE DELIVERY SYSTEM, THE BARE SPRING CONVERTED TO THE PROPER ALIGNMENT BUT THE STENT GRAFT WAS IMPLANTED WITH AN OVERLAP INTO THE PREVIOUS IMPLANTED DISTAL MAIN. A THIRD TALENT TAA PROXIMAL MAIN BODY WAS INSERTED INTO THE PROXIMAL LESION AND AGAIN, THE BARE SPRING OPENED WITH MISALIGNMENT (REFERENCE FILE # 2953200-2011-00615). BY WITHDRAWING THE DELIVERY SYSTEM SLIGHTLY DISTAL, THE PROXIMAL MAIN BODY WAS IMPLANTED NORMALLY WITH SEALING IN THE PROXIMAL ZONE. NEXT A PROXIMAL EXTENSION WAS IMPLANTED INTO THE MOST PROXIMAL ZONE. THE PROCEDURE WAS ENDED WITHOUT ENDOLEAK AND/OR ANY CLINICAL EVENT DUE TO THE MISALIGNED SPRINGS. NO CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE. REFERENCE FILE # 2953200-2011-00613, 2953200-2011-00615.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THROACIC STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00546328

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention