BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 3020085 · Received March 25, 2013

    Report

    Report Number
    2953200-2013-00536
    Event Type
    Injury
    Date Received
    March 25, 2013
    Date of Event
    April 12, 2013
    Report Date
    June 3, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: (FILM). RESULTS: PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (TYPE II ENDOLEAK). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (TYPE II ENDOLEAK).

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: ENDOLEAK. DISEASE PROGRESSION. CONCLUSION: DISEASE PROGRESSION.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF 6.5 CM DIAMETER THORACIC AORTIC ANEURYSM IN ZONE 4 APPROXIMATELY 26 MONTHS AGO. THE PROXIMAL NECK WAS 32-30 MM IN DIAMETER. THE COMMON ILIAC ARTERIES WERE MODERATELY CALCIFICATION. THE PROXIMAL AND DISTAL AORTIC NECK HAD MILD THROMBUS. AT THE TWO YEAR FOLLOW-UP A PROXIMAL TYPE I ENDOLEAK WAS SEEN ON THE CT SCAN. THE ANEURYSM EXPANDED 9 MM IN THE PAST YEAR. IT WAS REPORTED THAT THE CAUSE OF THE EVENT WAS MOST LIKELY DUE TO EXPANSION OF THE AORTA. THE PATIENT WILL BE MONITORED. NO ADDITIONAL 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 THERE WAS ANEURYSM ENLARGEMENT DUE TO AN ENDOLEAK AND A DEVELOPMENT OF A NEW ANEURYSM PROXIMAL TO THE TALENT STENT GRAFT. THE PROXIMAL PORTION OF THE THORACIC AORTA WAS CONVERTED WITH AN ARTIFICIAL GRAFT FOLLOWED BY IMPLANT OF TWO VALIANT STENT GRAFTS WHICH WERE IMPLANTED TO COVER THE TWO PREVIOUSLY IMPLANTED TALENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS STABLE.

    Description of Event or Problem · 1

    FILMS FROM 2 YEARS POST-IMPLANT WERE RECEIVED AND REVIEWED AS FOLLOWS: SIGNIFICANT CALCIFICATION WAS OBSERVED WITHIN THE AORTIC ARCH. THE STENT GRAFT WAS POSITIONED IN THE DESCENDING THORACIC; JUST DISTAL TO THE ARCH. CONTRAST WAS SEEN NEAR THE MID-LENGTH OF THE STENT GRAFTS (OVERLAPPING SECTION). THIS MAY BE A TYPE III ENDOLEAK; COULD NOT DETERMINE IF A JUNCTION OR FABRIC TYPE III ENDOLEAK. THERE IS ALSO A POSSIBLE TYPE II ENDOLEAK. NO PROXIMAL OR DISTAL TYPE I COULD BE SEEN CONFIRMED THE PROXIMAL STENT GRAFT OD WAS 37X38MM, AND THE DISTAL OD WAS 30X33MM. THE CAUSE OF THE TYPE III ENDOLEAK COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122602 TALENT THORACIC STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Required Intervention