BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 3791707 · Received May 6, 2014

    Report

    Report Number
    9612164-2014-00494
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 8, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (STENT DEFORMATION). PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (CALCIFIED LESION). NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED (DEVICE OR PROCEDURAL IMAGES WERE NOT RETURNED FOR REVIEW). EVALUATION CONCLUSIONS: INHERENT RISK OF PROCEDURE (STENT DEFORMATION). DEVICE FAILURE RELATED TO PATIENT CONDITION (CALCIFIED LESION). UNABLE TO CONFIRM COMPLAINT (DEVICE OR PROCEDURAL IMAGES WERE NOT RETURNED FOR REVIEW). (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN INTENDED TO DEPLOY A 2.5 X 30 MM RESOLUTE INTEGRITY DRUG ELUTING STENT TO TREAT A MID LAD LESION. IT WAS REPORTED THAT DURING AN ATTEMPT TO CROSS A CALCIFIED AREA, STRUTS OF THE STENT BECAME LIFTED. THE PROCEDURE WAS COMPLETED USING A 3.0 X 38 MM RESOLUTE INTEGRITY STENT. NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271988 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1