BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 5969593 · Received September 22, 2016

    Report

    Report Number
    9612164-2016-00993
    Event Type
    Malfunction
    Date Received
    September 22, 2016
    Date of Event
    November 8, 2012
    Report Date
    August 25, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LITERATURE SOURCE: ¿PROCEDURAL TRAUMA RISKS LONGITUDINAL SHORTENING OF THE PROMUS ELEMENTTM STENT PLATFORM¿ SHANNON ET AL CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 81:810¿817 (2013) EVENT DATE IS THE PUBLICATION DATE OF THE ARTICLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE THAT PNE ENDEAVOR RESOLUTE RX DRUG ELUTING STENT WAS INVOLVED IN A GUIDE CATHETER INDUCED LONGITUDINAL STENT DEFORMATION. THE ARTICLE REPORTED ONE CASE OF CONCERTINA OR LONGITUDINAL STENT SHORTENING OF THE ENDEAVOR RESOLUTE, WHICH OCCURRED EXCLUSIVELY IN THE LMS AND RESULTED FROM GUIDE CATHETER TRAUMA DELIVERED ANTEGRADELY. PLEASE NOTE THAT THIS DEVICE, ENDEAVOR RESOLUTE IS NOT MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES MARKETED PRODUCT RESOLUTE INTEGRITY. THIS EVENT IS BEING REPORTED ONLY AS A MALFUNCTION BECAUSE OF THE SIMILAR DEVICE REQUIREMENT IN 803 WHICH IS LIMITED TO MALFUNCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623078 ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1