BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT

    MDR report key: 3243053 · Received July 23, 2013

    Report

    Report Number
    2953200-2013-01414
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    March 16, 2011
    Report Date
    August 31, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK, MIGRATION); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANATOMY RELATED; SHORT LANDING ZONE AND TORTUOUS ANATOMY); FAILURE TO FOLLOW INSTRUCTIONS (NOT IMPLANTING A PROXIMAL MAIN DEVICE AND NOT OVERLAPPING PROPERLY). CONCLUSION: KNOWN INHERENT RISK OF A PROCEDURE (ENDOLEAK, MIGRATION); FAILURE TO FOLLOW INSTRUCTIONS (NOT IMPLANTING A PROXIMAL MAIN DEVICE AND NOT OVERLAPPING PROPERLY); DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANATOMY RELATED; SHORT LANDING ZONE AND TORTUOUS ANATOMY).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A FUSIFORM 55 MM DIAMETER AND 120 MM IN LENGTH THORACIC AORTIC ANEURYSM. THE PROXIMAL NECK WAS 36 MM IN DIAMETER. THE DISTAL NECK WAS 32 MM IN DIAMETER. THE COMMON ILIAC ARTERY WAS MILDLY CALCIFIED. IT WAS REPORTED THAT THE ANEURYSM HAD EXPANDED TO 64 MM IN DIAMETER DUE TO A TYPE IB ENDOLEAK. ADDITIONAL TALENT DEVICES WERE IMPLANTED AND THE ENDOLEAK RESOLVED. THE CAUSE OF THIS EVENT WAS A SHORT LANDING ZONE. RELATIONSHIP TO THE PRODUCT IS NO, RELATIONSHIP TO PROCEDURE IS UNKNOWN. IT WAS REPORTED AT THE 2 YEAR FOLLOW UP THAT THE ANEURYSM WAS 64 MM IN DIAMETER. AT THE 3 YEAR FOLLOW UP THE ANEURYSM WAS 73.5 MM IN DIAMETER AND A MIGRATION AND A TYPE III ENDOLEAK WAS NOTED (DETAILS UNKNOWN). AT THE SAME TIME, THE DEVICES FELL INTO THE ANEURYSM SAC AND STENT GRAFT OF OUTSIDE GREATER CURVATURE WAS DROPPED OFF AND TYPE III ENDOLEAK WAS CONFIRMED. ANOTHER MANUFACTURER¿S DEVICE WAS IMPLANTED. THE CAUSE OF THIS EVENT WAS SEVERE VESSEL CURVATURE, DROP-OFF OF STENT GRAFT TO THE OUTSIDE GREATER CURVATURE BECAUSE OF LARGE-SIZED ANEURYSM AND SHORT OVERLAPPING ZONE WITH ONLY ONE STENT LENGTH. RELATIONSHIP TO THE PRODUCT IS YES, RELATIONSHIP TO PROCEDURE IS YES. AT THE 4 YEAR FOLLOW UP THE ANEURYSM WAS 71 MM IN DIAMETER THERE WAS NO MIGRATION NOTED AND A TYPE IA ENDOLEAK WAS NOTED. THE TYPE IA ENDOLEAK WAS CONFIRMED COMING FROM THE PROXIMAL SIDE OF ANOTHER MANUFACTURER¿S DEVICE. THE PATIENT WILL BE MONITORED BY THE PHYSICIAN. PER THE PHYSICIAN THERE IS NO CAUSALITY WITH TALENT DEVICE. RELATIONSHIP TO THE PRODUCT IS NO, RELATIONSHIP TO PROCEDURE IS NO. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED, REGARDING THE PHYSICIAN ASSESSMENT OF DEVICE AND PROCEDURE RELATION. PER THE PHYSICIAN, THE CAUSE OF THE ANEURYSM ENLARGEMENT AND TYPE IB ENDOLEAK WAS DETERMINED TO HAVE NO CAUSALITY WITH THE RELEVANT DEVICE, BUT WITH THE PROCEDURE. PER THE PHYSICIAN, THE CAUSE OF THE STENT GRAFT MIGRATION AND TYPE III ENDOLEAK WAS CAUSED BY COMBINED FACTOR AND IT IS UNDENIABLE THE RELATIONSHIP WITH THE RELEVANT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343730 TALENT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention