BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 3233574 · Received July 18, 2013

    Report

    Report Number
    9612164-2013-00724
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (FAILURE TO DELIVER AND DEFORMATION), PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (LESION MORPHOLOGY), 90% STENOSIS AND SEVERE CALCIFICATION. RELATED TO ANOTHER DEVICE (RELATED TO THE PREVIOUSLY DEPLOYED STENT IN THE VESSEL). NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED (DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW). EVALUATION CONCLUSIONS: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (LESION MORPHOLOGY), 90% STENOSIS AND SEVERE CALCIFICATION. INHERENT RISK OF PROCEDURE (FAILURE TO DELIVER AND DEFORMATION) RELATED TO ANOTHER DEVICE (RELATED TO THE PREVIOUSLY DEPLOYED STENT IN THE VESSEL). (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN ATTEMPTED TO DEPLOY A RESOLUTE INTEGRITY STENT AT SEVERELY CALCIFIED LESION AT 1ST DIAGONAL WITH 90% STENOSIS <(>&<)> MODERATE TORTUOSITY, BUT IT WAS UNABLE TO CROSS THE LESION. WHEN HE WITHDREW THE STENT, THE STENT STUCK ON THE OTHER STENT WHICH HAD BEEN DEPLOYED PREVIOUSLY AT LAD AND SHORTENED FROM 18MM TO 8MM. THE STENT WAS WITHDRAWN ON THE DELIVERY SYSTEM BUT IT WAS DISPLACED. NO PATIENT INJURY REPORTED. THE DEVICE WAS DISCARDED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334463 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006418183

    Patients

    Seq Age Sex Outcome Treatment
    1