BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM

    MDR report key: 2060801 · Received March 10, 2011

    Report

    Report Number
    9612164-2011-00047
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 17, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION: RESULTS: PATIENT VESSEL MORPHOLOGY. DIRECT HANDLING OF THE STENT AND USE OF FORCE. STENT DEFORMATION AND FAILURE TO DELIVER DEVICE. CONCLUSION: PATIENT VESSEL MORPHOLOGY. DIRECT HANDLING OF THE STENT AND USE OF FORCE. EVALUATION SUMMARY: A NUMBER OF STRUTS ON THE 6TH AND 14TH PROXIMAL STENT SEGMENTS WERE RAISED AND STRETCHED DISTALLY.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A 2.75 MM DIAMETER X 24 MM LENGTH ENDEAVOR RESOLUTE RAPID EXCHANGE (RX) DRUG ELUTING STENT TO TREAT A LESION IN THE LCX IN A PATIENT. IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE STENT IN THE LCX. THE LCX WAS REPORTED TO BE VERY TORTUOUS AND FORCE WAS USED IN AN ATTEMPT TO ADVANCE THE STENT. ON REMOVAL OF THE DEVICE, DAMAGE WAS NOTED TO THE STENT SEGMENTS. THE PATIENT RECEIVED ANOTHER RESOLUTE DEVICE OF THE SAME SIZING WITH NO ISSUES NOTED. NO PATIENT INJURY OCCURRED AND NO CLINICAL SEQUELAE WERE REPORTED. 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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0001160668

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK