BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM

    MDR report key: 2093080 · Received April 14, 2011

    Report

    Report Number
    9612164-2011-00233
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 13, 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): RESULTS: (SOME CALCIFICATION, SMALLER SIZE STENT SUBSEQUENTLY IMPLANTED WITHOUT DIFFICULTY), (USE OF FORCE), (STENT DAMAGE, FAILURE TO DELIVER THE STENT). CONCLUSIONS: (SOME CALCIFICATION, SMALLER SIZE STENT SUBSEQUENTLY IMPLANTED WITHOUT DIFFICULTY), (USE OF FORCE). EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. THE STENT WAS POSITIONED ON THE BALLOON AS PER SPECIFICATION. A NUMBER OF STRUTS ON THE 8TH AND 9TH PROXIMAL STENT SEGMENTS WERE DEFORMED, RAISED AND PULLED DISTALLY OVER THE 10TH AND 11TH SEGMENTS. THE DISTAL TIP WAS SLIGHTLY FLARED INDICATING THAT IT MAY HAVE BEEN STUBBED DURING ADVANCEMENT. 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 DELIVER A 2.25 MM DIAMETER X 18 MM LENGTH ENDEAVOR RESOLUTE RAPID EXCHANGE (RX) DRUG-ELUTING STENT THROUGH A SAPHENOUS VEIN GRAFT THE NATIVE CORONARY VESSEL. THE TARGET LESION WAS REPORTED TO EXHIBIT SOME CALCIFICATION. THE LESION WAS PRE-DILATED ONCE USING A 1.5 MM X 12 MM BALLOON AT 12 ATMS. 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. FORCE WAS REQUIRED TO WITHDRAW THE DEVICE. 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 A SMALLER SIZE RESOLUTE STENT. THE FINAL RESULT WAS REPORTED TO BE VERY GOOD AN 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 0001140171

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK