BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 3863853 · Received June 10, 2014

    Report

    Report Number
    9612164-2014-00617
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 2.50 MM DIAMETER X 30 MM LENGTH RESOLUTE INTEGRITY RX DRUG ELUTING STENT WAS IMPLANTED INTO THE PATIENT APPROXIMATELY 149 DAYS POST ITS EXPIRY. THE DEVICE HAD BEEN REMOVED FROM ITS PACKAGING AS PER THE REQUIREMENTS OF THE IFU. THE DEVICE WAS NOT INSPECTED AND A NEGATIVE PREP WAS NOT PERFORMED. THE TARGET LESION HAD 90% STENOSIS WITH MODERATE CALCIFICATION AND WAS ASSOCIATED WITH AN SVG. THE TORTUOSITY WAS MODERATE. THERE WAS NO INTERVENTION AS A RESULT OF THIS EVENT. THE PATIENT CONDITION POST PROCEDURE WAS REPORTED AS 'STABLE WITH NO PROBLEMS'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340774 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006203118

    Patients

    Seq Age Sex Outcome Treatment
    1