BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM

    MDR report key: 1880986 · Received October 5, 2010

    Report

    Report Number
    2953200-2010-01889
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 6, 2010
    Report Date
    September 6, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (OTHER) BASED ON LIMITED INFORMATION AVAILABLE, NO ROOT CAUSE FOR THIS COMPLAINT CAN BE DETERMINED; FAILURE TO DELIVER AND STENT DEFORMATION.

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO ADVANCE A 2.25 MM DIAMETER X 30 MM LENGTH ENDEAVOR RESOLUTE RAPID EXCHANGE STENT INTO THE PATIENT. IT WAS REPORTED THAT THE PHYSICIAN FOUND IT DIFFICULT TO ADVANCE THE STENT. THE STENT WAS WITHDRAWN AND UPON INSPECTION, IT WAS FOUND TO HAVE SOME RAISED STRUTS. ANOTHER STENT (ALSO RESOLUTE) WAS INSERTED AND WORKED PROPERLY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED. PLEASE NOTE THAT THIS DEVICE ERES22530X IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT EN22530UX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000935571

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK