BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM

    MDR report key: 2093081 · Received April 14, 2011

    Report

    Report Number
    9612164-2011-00234
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 16, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL, RESULTS, CONCLUSIONS: (SEVERE CALCIFICATION, 90% STENOSIS). (USE OF FORCE). (STENT DAMAGE, FAILURE TO DELIVER THE STENT). EVAL SUMMARY: THE DEVICE WAS RETURNED TO THE MFG FACILITY FOR EVAL. THE STENT WAS POSITIONED ON THE BALLOON AS PER SPEC. THE 8TH DISTAL STENT SEGMENT WAS RAISED, DEFORMED AND PULLED DISTALLY. PLEASE NOTE THAT THIS DEVICE (B)(4) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A 2.5 MM DIAMETER X 30 MM LENGTH ENDEAVOR RESOLUTE RAPID EXCHANGE (RX) DRUG-ELUTING STENT TO TREAT A LESION IN THE MID CX. THE TARGET LESION WAS REPORTED TO EXHIBIT 90% STENOSIS AND SEVERE CALCIFICATION. THE LESION WAS PRE-DILATED ONCE USING A 2.0 MM X 20 MM BALLOON AT 12 ATM'S. RESISTANCE WAS ENCOUNTERED WHILE ATTEMPTING TO ADVANCE THE ENDEAVOR RESOLUTE STENT TO THE TARGET LESION, AND FORCE WAS USED IN AN EFFORT TO ADVANCE THE DEVICE. THE ENDEAVOR RESOLUTE STENT COULD NOT REACH THE LESION AND THE DEVICE WAS REMOVED. DAMAGE TO THE STENT DELIVERY SYSTEM WAS OBSERVED ON REMOVAL. THE DEVICE HAD BEEN INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE TARGET LESION WAS SUCCESSFULLY TREATED USING TWO SMALLER SIZE RESOLUTE STENTS. THE FINAL RESULT WAS REPORTED TO BE VERY GOOD AND NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA A202664113

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK