BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 3213286 · Received July 9, 2013

    Report

    Report Number
    9612164-2013-00698
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 24, 2013
    Report Date
    June 10, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE IS APPROXIMATE. EVALUATION CODES RESULTS AND CONCLUSIONS: STENT DEFORMATION IS LISTED IN THE PRODUCT IFU AS AN INHERENT RISK OF CORONARY STENTING PROCEDURES. THE ROOT CAUSE OF THE REPORTED EVENT WAS MOST LIKELY PROCEDURAL RELATED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO DEPLOY A RESOLUTE INTEGRITY 2.25 X 30MM RX DRUG ELUTING STENT. THE DEVICE WAS INSPECTED BEFORE USE AND NO ABNORMALITIES WERE NOTED. IT IS REPORTED THAT RESISTANCE WAS ENCOUNTERED DURING DELIVERY / REMOVAL OF THE DEVICE. IT IS REPORTED THAT THE BALLOON WAS STICKING TO GUIDE BEFORE STENT WAS DEPLOYED RESULTING IN STENT DEFORMATION. THE DELIVERY SYSTEM, WIRE AND GUIDE WERE REMOVED FROM THE PATIENT AS A SINGLE UNIT. THE PROCEDURE WAS COMPLETED USING 2 NON¿MEDTRONIC STENTS. EVALUATION SUMMARY THE DISTAL SHAFT HAD BEEN CUT 9.5CM FROM THE DISTAL TIP. INITIAL MANDREL AND GUIDEWIRE MOVEMENT FAILED DUE TO RESIDUE IN THE INNER LUMEN. THE RESIDUE COULD NOT BE TOTALLY REMOVED, HOWEVER, IS MOST LIKELY DUE TO CRYSTALLIZED SALINE/BLOOD FOLLOWING FLUSHING OF THE GUIDE WIRE LUMEN PRIOR TO THE PROCEDURE, LOADING ON TO THE GUIDE WIRE AND INSERTION. A NUMBER OF THE PROXIMAL AND MID STENT SEGMENTS WERE SEVERELY BUNCHED AND OVERLAPPING. THE REMAINING SEGMENTS WERE INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314457 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006690521

    Patients

    Seq Age Sex Outcome Treatment
    1