BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 2922215 · Received January 18, 2013

    Report

    Report Number
    9612164-2013-00087
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 21, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS AND CONCLUSIONS: (TARGET LESION EXHIBITED EXCESSIVE TORTUOSITY AND SEVERE CALCIFICATION). (FORCE USED IN AN EFFORT TO ADVANCE AND WITHDRAW DEVICE). (STENT DAMAGE, FAILURE TO DELIVER THE STENT).

    Description of Event or Problem · 1

    THE PHYSICIAN INTENDED TO USE A RESOLUTE INTEGRITY DRUG-ELUTING STENT TO TREAT A TYPE C LESION IN THE CX WITH 95% STENOSIS, EXCESSIVE TORTUOSITY AND SEVERE CALCIFICATION. THE TARGET LESION WAS PRE-DILATED USING A SPRINTER LEGEND BALLOON AND A NON-MEDTRONIC BALLOON FOR 3 INFLATIONS AT 14 ATM'S. ABOUT 60% STENOSIS REMAINED FOLLOWING PRE-DILATION. RESISTANCE WAS ENCOUNTERED ADVANCING THE RESOLUTE INTEGRITY DEVICE ACROSS THE TARGET LESION AND FORCE WAS USED IN AN EFFORT TO ADVANCE THE DEVICE. IT WAS REPORTED THAT THE DEVICE COULD NOT CROSS DUE TO THE EXCESSIVE TORTUOSITY OF THE VESSEL AND THE SEVERE CALCIFICATION. TWO UNSUCCESSFUL ATTEMPTS WERE MADE TO DELIVER THE DEVICE. THE STENT WAS REPORTED TO BE DAMAGED ON REMOVAL. THE DEVICE HAD BEEN INSPECTED PRIOR TO USE WITH NO ABNORMALITIES NOTED. A 2.25 X 14 MM RESOLUTE INTEGRITY STENT WAS SUCCESSFULLY USED TO TREAT THE TARGET LESION. THE PHYSICIAN DECIDED NOT TO IMPLANT ANOTHER STENT DUE TO THE PATIENT'S HEALTH CONDITION. THE FINAL RESULT WAS EXCELLENT AND NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27422 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006193551

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR