BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALENT AAA

    MDR report key: 3841224 · Received May 30, 2014

    Report

    Report Number
    2953200-2014-01084
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    March 27, 2014
    Report Date
    July 14, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: UNKNOWN CAUSE OF DAMAGED VALVE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A TALENT OCCLUDER STENT GRAFT SYSTEM WAS INSERTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. DURING THE INDEX PROCEDURE IT WAS REPORTED THAT THE INTRODUCER SHEATH PRESENTED DIFFICULTY IN NAVIGATION. WHEN IT WAS INTRODUCED IN THE CAPSULE, THE OCCLUDER DID NOT NAVIGATE WITHIN THE INTRODUCER. THE PHYSICIAN REPLACED THE OCCLUDER WITH ANOTHER OCCLUDER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO INJURIES TO THE PATIENT. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS DOING FINE.

    Description of Event or Problem · 1

    FURTHER INVESTIGATION WAS PERFORMED. BASED ON THE REVIEW OF THE RETURNED TALENT OCCLUDER UNIT THE SHEATH VALVE WAS DISLODGED FROM ITS CORRECT POSITION. THERE WAS NO ISSUE NOTED WITH ANY OF THE COMPONENTS. BASED ON THE EVENT REPORT THERE WAS NO ISSUE WHEN PLACING THE DILATOR COMPONENT INSIDE THE SHEATH COMPONENT. THERE WAS ALSO NO ISSUE WHEN FLUSHING THE SHEATH COMPONENT. THIS INDICATES THAT THE SHEATH VALVE COMPONENT WAS IN THE CORRECT POSITION DURING THIS PART OF THE PROCEDURE. BASED ON THIS THE SHEATH VALVE WAS DISLODGED SUBSEQUENT TO THIS. IT IS POSSIBLE TO DISLODGE THE SHEATH VALVE IF THE DILATOR COMPONENT IS INSERTED AT AN ANGLE; HOWEVER THERE IS A CAUTION NOTE IN THE IFU REGARDING THIS.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED AND ITS EVALUATION IS COMPLETE. THE EVENT WAS CONFIRMED; THE CARTRIDGE WOULD NOT INSERT PROPERLY INTO THE VALVE. THE ROOT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, THE DAMAGED VALVE MAY HAVE PREVENTED PROPER SEATING OF THE CARTRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319575 TALENT AAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V03994998

    Patients

    Seq Age Sex Outcome Treatment
    1