BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 3040171 · Received April 2, 2013

    Report

    Report Number
    MW5029633
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    December 4, 2012
    Report Date
    April 2, 2013
    Manufacturer
    MEDTRONIC
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, TRANSFERRED FROM OUTLYING FACILITY WHERE DIAGNOSTIC CATH HAD BEEN PERFORMED DUE TO CHEST PAIN. FILMS REVEAL 80% STENOSIS IN PROXIMAL CIRCUMFLEX. A 3.0 X 10 FLEXTOME RX, 3.5 X 15 RESOLUTE INTEGRITY RX DEPLOYED, AND 3.5 X 15 NC QUANTUM APEX MR TO POST DILATE WITH GOOD RESULTS AND TIMI III FLOW. DISCHARGED ON MEDICATIONS INCLUDING ASA AND PLAVIX. URGENT OFFICE VISIT (B)(6) 2012 STATES PATIENT HAS BEEN HAVING CONSTANT CHEST PAIN SINCE STENTING. ADMITTED TO OUTLYING EMERGENCY ROOM (B)(6) 2012 AND DIAGNOSTIC CATH REVEALS 70% OCCLUSION WITH THROMBUS IN PROXIMAL CIRCUMFLEX STENT. TRANSFERRED TO OUR FACILITY AND TAKEN TO CCL (B)(6) 2012. THROMBECTOMY PERFORMED, AND 3.5 X 12 NC QUANTUM APEX OTW RESTORED TIMI III FLOW. TREATED WITH MEDICATIONS INCLUDING ASA, ANGIOMAX, INTEGRILIN, AND PLAVIX. PLAVIX CHANGED TO EFFIENT, AND PATIENT DISCHARGED ON MEDICATIONS INCLUDING ASA AND EFFIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134972 RESOLUTE INTEGRITY RX RESOLUTE INTEGRITY RX NIQ MEDTRONIC 0006102095

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention