BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALENT

    MDR report key: 3243106 · Received July 23, 2013

    Report

    Report Number
    2953200-2013-01416
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    July 21, 2010
    Report Date
    June 27, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK), (UNKNOWN CAUSE OF EVENT). CONCLUSION: (UNKNOWN CAUSE OF EVENT), KNOWN INHERENT RISK OF A PROCEDURE (ENDOLEAK).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A SACCULAR 48MM IN DIAMETER AND 45 MM IN LENGTH THORACIC AORTIC ANEURYSM. THE PROXIMAL NECK WAS 30 MM IN DIAMETER. THE DISTAL NECK WAS 33 MM IN DIAMETER. THERE WAS MILD CALCIFICATION IN THE COMMON ILIAC ARTERY AND THE PROXIMAL NECK. THERE WAS MILD THROMBUS IN THE PROXIMAL NECK AND DISTAL NECK. IT WAS REPORTED THAT A CT FOUND A TYPE III ENDOLEAK JUNCTIONAL ENDOLEAK. THE PATIENT HAD RETURNED FOR FOLLOW UP APPOINTMENTS BUT THE ENDOLEAK HAD NOT RESOLVED; HOWEVER, THERE WAS NO ANEURYSM EXPANSION. THE PATIENT WAS MONITORED BY THE PHYSICIAN. TWO MONTHS AGO, IT WAS NOTED THAT THE ENDOLEAK HAD RESOLVED. PER THE PHYSICIAN THE CAUSE IS UNKNOWN. RELATIONSHIP TO THE PRODUCT IS UNKNOWN, RELATIONSHIP TO PROCEDURE IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343398 TALENT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR