BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 3041945 · Received April 9, 2013

    Report

    Report Number
    9612164-2013-00380
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Report Date
    March 13, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS AND CONCLUSIONS: (STENT DAMAGE, FAILURE TO DELIVER THE STENT). (ROOT CAUSE OF EVENT CANNOT BE DETERMINED BASED ON LIMITED INFORMATION PROVIDED).

    Description of Event or Problem · 1

    A RESOLUTE INTEGRITY RX DRUG-ELUTING STENT WAS INTENDED TO BE USED TO TREAT A PATIENT. THE ATTEMPT WAS UNSUCCESSFUL. THE RESOLUTE INTEGRITY RX DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY AND DAMAGE WAS NOTED TO THE STENT ON INSPECTION. NO CLINICAL SEQUELAE WERE REPORTED. THE STENT WAS POSITIONED ON THE BALLOON BETWEEN THE INNER MARKERS AS PER SPECIFICATION; HOWEVER, THE STENT HAD BEEN PARTIALLY DEPLOYED AND A "T-BONE SHAPE" WAS EVIDENT. THE PROXIMAL AND DISTAL ENDS OF THE BALLOON FOLDS WERE OPEN. STRUTS ON THE 1ST AND 4TH DISTAL SEGMENTS AND STRUTS ON THE 4TH PROXIMAL SEGMENTS WERE RAISED. THE FIRST TO SIXTH PROXIMAL SEGMENTS WERE FLATTENED. THE DISTAL TIP WAS FLARED AND DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146179 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0004746705

    Patients

    Seq Age Sex Outcome Treatment
    1