BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1172581 · Received September 19, 2008

    Report

    Report Number
    2953200-2008-00830
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 22, 2008
    Report Date
    August 22, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODES, RESULTS: DIFFICULT ACCESS. EVALUATION CODES, CONCLUSION: DIFFICULT ACCESS. EVALUATION SUMMARY: THE DEVICE WAS RECEIVED AND ITS EVALUATION HAS BEEN COMPLETED. THE SHEATH WAS RELATIVELY STRAIGHT. THERE WERE KINKS ON THE GRAFT COVER AT 115MM AND 150MM. THERE WERE TWO INDENTATION MARKS OBSERVED ON THE PROXIMAL EDGE OF THE GRAFT COVER, LIKELY CAUSED BY THE REPORTED RESISTANCE DUE TO PLAGUE IN THE VESSEL. THE STENT GRAFT DEPLOYED FINE IN THE LAB.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS INSERTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THIS WAS KNOWN TO BE A DIFFICULT ACCESS; HOWEVER, ENDOVASCULAR TREATMENT WAS THE ONLY OPTION FOR THE PATIENT. THE DECISION WAS MADE TO PROCEED WITH THE CASE AND THE DECISION WAS MADE TO HAVE ANOTHER MANUFACTURER'S DEVICE AVAILABLE IN CASE ACCESS WAS DIFFICULT. THE PATIENT WAS PREPPED, DRAPED, AND CUT-DOWN OF THE RIGHT FEMORAL ARTERY PERFORMED. A LUNDERQUIST WIRE POSITIONED IN THE DESCENDING THORACIC AORTA AND A DILATOR SET OF 20 AND 24 FR FROM ANOTHER MANUFACTURER WAS UTILIZED. THESE PASSED WITH SOME RESISTANCE. A TALENT WAS INSERTED INTO ARTERIOTOMY OVER THE LUNDERQUIST WIRE AND ADVANCED APPROXIMATELY 4CM WHERE RESISTANCE WAS MET (SEE MFR # 2953200-2008-00829). THIS DEVICE WAS REMOVED AND INSPECTED ON THE TABLE AND WAS FOUND TO HAVE A "BURRING" OF THE LEADING EDGE OF THE OUTER DELIVERY SHEATH, LIKELY DUE TO PLAQUE WITHIN THE EXTERNAL ILIAC ARTERY. BURRING WAS NOT EVIDENT ON INITIAL DEVICE PREP. THE DILATORS WERE USED FOR THE SECOND TIME AT THIS POINT AND A SECOND DEVICE WAS INSERTED; HOWEVER, THE SAME RESISTANCE WAS MET. ANOTHER MANUFACTURER'S AORTA-UNI-ILIAC WAS USED TO COMPLETE THE CASE AND THEN A FEMORAL TO FEMORAL BYPASS WAS PERFORMED POST IMPLANT. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA V00105282

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK