BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX CORONARY STENT SYSTEM

    MDR report key: 2160947 · Received June 16, 2011

    Report

    Report Number
    9612164-2011-00587
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 22, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: ROOT CAUSE OF EVENT IS UNDETERMINED. STENT DAMAGE, FAILURE TO DELIVER THE STENT. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN (ROOT CAUSE OF EVENT IS UNDETERMINED). EVAL SUMMARY: THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY FOR EVAL. THE STENT WAS POSITIONED BETWEEN THE MARKER BANDS AS PER SPECIFICATIONS. THE 6TH DISTAL STENT SEGMENT WAS RAISED AND DEFORMED.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A 2.5 MM DIAMETER X 14 MM LENGTH RESOLUTE INTEGRITY RAPID EXCHANGE (RX) DRUG-ELUTING STENT TO TREAT A PT. IT WAS REPORTED THAT THE STENT WAS DIFFICULT TO MOVE THROUGH THE VESSEL AND THAT THE STENT MAY BE DEFECTIVE. NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTE INTEGRITY RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0005607446

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK