BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 3091690 · Received May 3, 2013

    Report

    Report Number
    9612164-2013-00506
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 8, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODES, RESULTS: INHERENT RISK OF PROCEDURE - (STENT THROMBOSIS AND INCOMPLETE STENT EXPANSION); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE - (MODERATE CALCIFICATION, INFORMATION STATED THAT THE STENT FAILED TO EXPAND SUFFICIENTLY DUE TO THE PRESENCE OF CALCIFICATION. INSUFFICIENT STENT EXPANSION RESULTED IN THE STENT THROMBOSIS). (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW CONCLUSIONS: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION - (MODERATE CALCIFICATION, INFORMATION STATED THAT THE STENT FAILED TO EXPAND SUFFICIENTLY DUE TO THE PRESENCE OF CALCIFICATION. INSUFFICIENT STENT EXPANSION RESULTED IN THE STENT THROMBOSIS). INHERENT RISK OF PROCEDURE - (STENT THROMBOSIS AND INCOMPLETE STENT EXPANSION). (B)(4).

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE, RESOLUTE INTEGRITY DRUG-ELUTING STENT WAS DEPLOYED AT LAD. PROCEDURE ENDED AFTER POST-DILATATION AND IVUS CHECK. 25% STENOSIS REMAINED. INSUFFICIENT STENT EXPANSION AT MID STENT WAS OBSERVED DUE TO CALCIFICATION. ANTI-PLATELET DRUGS OF ASA AND PRETAAL WERE DOSED TO THE PATIENT AND PRETALL WAS PLANNED TO BE CHANGED TO PLAVIX. HOWEVER, IT WAS NOT CHANGED. THE PATIENT PRESENTED CHEST PAIN AND TRANSFERRED TO THE HOSPITAL. CAG SHOWED THROMBOTIC OCCLUSION AT THE DEPLOYED RESOLUTE INTEGRITY STENT. THROMBUS WAS ASPIRATED AND REVACULARIZATION WAS CARRIED OUT USING BALLOON TO START REFLOW. THE PATIENT STATUS IS GOOD POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195055 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006321428

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ASPIRIN AND PRETAAL