BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT CAPTIVIA FF

    MDR report key: 2181377 · Received July 21, 2011

    Report

    Report Number
    2953200-2011-01309
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL: RESULTS: (ENDOLEAK). RESULTS/CONCLUSION: (PRE-OPERATIVE DISSECTION). (TYPE II ENDOLEAK).

    Description of Event or Problem · 1

    A TALENT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A PRE-OPERATIVE DISSECTION. VESSEL MORPHOLOGY WAS REPORTED AS THE THORACIC AORTA HAD A BOVINE ARCH WHICH MEASURED 29 - 31 MM IN DIAMETER; THE DISSECTION WENT FROM 2 CM DISTAL TO THE SUBCLAVIAN ARTERY TO THE RCIA AND CREATED A 5.7 CM THORACIC ANEURYSM IN THE FALSE LUMEN. IT WAS REPORTED THAT A LEFT CAROTID TO SUBCLAVIAN BYPASS PROCEDURE WAS PERFORMED THE DAY BEFORE IMPLANT IN PREPARATION FOR THE ENDOVASCULAR PROCEDURE. THE STENT GRAFT WAS IMPLANTED RIGHT AT THE INNOMINATE ARTERY; HOWEVER, THERE WAS A MODERATE TYPE 1 ENDOLEAK THAT WAS BALLOONED FOUR TIMES, HOWEVER, THE ENDOLEAK DID NOT RESOLVE. THE PHYSICIAN DECIDED NOT TO INTERVENE AS THE PT COULD NOT TOLERATE ANY MORE CONTRAST DUE TO KIDNEY ISSUES, AND THE PHYSICIAN THINKS THE ENDOLEAK WILL SPONTANEOUSLY RESOLVE ON ITS OWN. AS SOON AS THE PT IS ABLE TO TOLERATE ANY MORE DYE, A CT SCAN WILL BE DONE. THERE WAS ALSO A RETROGRADE FILLING TYPE 2 ENDOLEAK COMING FROM THE SUBCLAVIAN ARTERY AND THIS WAS SUCCESSFULLY CORRECTED BY TYING OFF THE VERTEBRAL ARTERY. NO CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE AND WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT CAPTIVIA FF MIH MEDTRONIC CARDIOVASCULAR IRELAND NA V00566748

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention