BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 2802416 · Received October 24, 2012

    Report

    Report Number
    9612164-2012-01563
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 25, 2012
    Report Date
    September 25, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: FAILURE TO FOLLOW INSTRUCTIONS-FORCE USED, MOST LIKELY FURTHER CONTRIBUTED TO THE STENT DISLODGEMENT. PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE - CALCIFIED AND TORTUOUS LESION; INHERENT RISK OF PROCEDURE - STENT DISLODGEMENT; KNOWN INHERENT RISK OF PROCEDURE; DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION; USER ERROR CONTRIBUTED TO EVENT - FORCE USED, MOST LIKELY FURTHER CONTRIBUTED TO THE STENT DISLODGEMENT. (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS USING A RESOLUTE INTEGRITY TO TREAT A LESION IN THE PROXIMAL CIRCUMFLEX WHICH WAS REPORTED TO BE TORTUOUS AND CALCIFIED. NO ABNORMALITY WAS NOTED DURING PREPARATION OF THE DEVICE HOWEVER DURING ADVANCEMENT THE STENT DISLODGED FROM THE BALLOON PROXIMAL TO THE TARGET LESION. INFORMATION FROM THE ACCOUNT CONFIRMS THAT FORCE WAS USED DURING THE ATTEMPTED DELIVERY OF THE DEVICE. THE TARGET LESION WAS TREATED WITH ANOTHER STENT. NO CLINICAL SEQUELAE REPORTED. THE PATIENT WAS DISCHARGED IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006118676

    Patients

    Seq Age Sex Outcome Treatment
    1