BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 1993733 · Received February 11, 2011

    Report

    Report Number
    2953200-2011-00383
    Event Type
    Injury
    Date Received
    February 11, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (ENDOLEAK), (CAUSE OF TYPE III ENDOLEAK UNK). EVAL, CONCLUSION: (CAUSE OF TYPE III ENDOLEAK UNK).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM IN ZONE FOR APPROX ONE MONTH AGO. VESSEL MORPHOLOGY WAS REPORTED AS THE PROXIMAL WAS 22 MM AND DISTALLY IT WAS 18 MM. PRIOR TO THE STENT GRAFT IMPLANTATION THE BILATERAL RENAL ARTERIES AND THE SMA WERE BYPASSED TO THE COMMON ILIAC ARTERY. IT WAS REPORTED THAT THE (B)(4) WAS IMPLANTED FIRST AND IT WAS IMPLANTED DISTALLY VIA THE LEFT FEMORAL ARTERY. A (B)(4) WAS IMPLANTED PROXIMALLY. A TYPE 1 ENDOLEAK WAS SUSPECTED (REF MFR # 2953200-2011-00382). A (B)(4) WAS IMPLANTED PROXIMAL TO THE (B)(4); HOWEVER, THE ENDOLEAK REMAINED. THE PHYSICIAN DECIDED THE ENDOLEAK WAS A TYPE 3 FROM THE SEAM OF THE GRAFT AND IMPLANTED A (B)(4) INSIDE THE (B)(4), BUT THE ENDOLEAK REMAINED. THE PHYSICIAN SUSPECTED A JUNCTIONAL TYPE 3 ENDOLEAK AND A (B)(4) WAS IMPLANTED IN THE JUNCTION AREA OF THE (B)(4) AND (B)(4). TWO WEEKS POST IMPLANTATION THE ENDOLEAK WAS RESOLVED, WITHOUT FURTHER TREATMENT. 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 THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00546225

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention