BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALENT CONVERTER

    MDR report key: 2895656 · Received January 3, 2013

    Report

    Report Number
    2953200-2013-00012
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 6, 2012
    Report Date
    February 1, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK); (CAUSE OF ENDOLEAK IS UNKNOWN). CONCLUSION: (CAUSE OF ENDOLEAK IS UNKNOWN).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM AND A TALENT CONVERTER WERE IMPLANTED IN A PATIENT FOR ENDOVASCULAR TREATMENT OF A 5.2 CM DIAMETER ABDOMINAL AORTIC ANEURYSM APPROXIMATELY ONE MONTH AGO. THE AORTIC NECK MEASURES 21.4 MM, 21.3 MM, 22.7 MM, 23 MM IN DIAMETER FROM PROXIMAL TO DISTAL AND IT IS 20 MM IN LENGTH. PRE INDEX PROCEDURE THE PATIENT HAD AN OCCLUDED RIGHT COMMON ILIAC ARTERY. IT WAS REPORTED THAT AFTER THE STENT GRAFTS WERE SUCCESSFULLY IMPLANTED IT WAS NOTED THERE WAS A JETTING TYPE IV ENDOLEAK. THE STENT GRAFTS WERE BALLOONED; HOWEVER, THE TYPE IV ENDOLEAK DID NOT RESOLVE. NO INTERVENTION WAS PERFORMED AND THE PHYSICIAN IS GOING TO MONITOR THE PATIENT. NO CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: IT WAS REPORTED THAT DURING A ROUTINE FOLLOW UP CT SCAN, THE TYPE IV "JETTING" ENDOLEAK THAT WAS PREVIOUSLY REPORTED HAS SELF-RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3127 TALENT CONVERTER SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01024845

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Required Intervention