BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 3242189 · Received July 23, 2013

    Report

    Report Number
    9612164-2013-00732
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 24, 2013
    Report Date
    August 16, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: (INHERENT RISK OF PROCEDURE) - STENT EMBOLISM (DISLODGEMENT), (RELATED TO ANOTHER DEVICE) - PREVIOUSLY DEPLOYED STENTS IN VESSEL. (PATIENT'S CONDITION AFFECTED THE EFFECTIVENESS OF THE DEVICE) - LESION MORPHOLOGY, TORTUOUS LESION. (NO RESULTS AVAILABLE SINCE NO EVALUATION WAS PERFORMED) - NO DEVICE OR PROCEDURAL IMAGES WERE PROVIDED FOR REVIEW. CONCLUSIONS: (INHERENT RISK OF PROCEDURE) - STENT EMBOLISM DISLODGEMENT, (UNABLE TO CONFIRM COMPLAINT) - NO DEVICE OR PROCEDURAL IMAGES HAVE BEEN PROVIDED FOR REVIEW. (LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION) - LESION MORPHOLOGY, TORTUOUS LESION. (OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THE EVENT) - LESION MORPHOLOGY, PREVIOUSLY DEPLOYED STENTS IN VESSEL. (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN ATTEMPTED TO IMPLANT A 2.25 X 14 MM RESOLUTE INTEGRITY RX DEVICE INTO A TORTUOUS LESION IN THE PROXIMAL LCX VESSEL. THE VESSEL IS SAID TO HAVE PREVIOUS STENTS ALREADY IMPLANTED. IT IS REPORTED THE RESOLUTE STENT DISLODGED IN THE LCX WHILE BEING ADVANCED TO THE DISTAL PART OF THE LESION . THE PHYSICIAN USED A 1.25MM SPRINTER LEGEND BALLOON TO TREAT THE UN-DEPLOYED STENT, THE PHYSICIAN USED MULTIPLE DIFFERENT BALLOONS EVENTUALLY WORKING HIS WAY UP TO A 3.5MM NC SPRINTER BALLOON. THE PROXIMAL SECTION LOOKED GOOD ON ANGIOGRAPHY AND THERE WAS NORMAL BLOOD FLOW. THE DISTAL LESION WAS TREATED WITH A BALLOON ONLY. NO PATIENT INJURY WAS REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED: THE DISLODGED RESOLUTE INTEGRITY STENT WAS DEPLOYED IN AN UNINTENDED REGION AND NOT THE INTENDED TARGET VESSEL. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342880 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006719492

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention