BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 5731522 · Received June 17, 2016

    Report

    Report Number
    9612164-2016-00596
    Event Type
    Injury
    Date Received
    June 17, 2016
    Date of Event
    June 10, 2015
    Report Date
    May 18, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). JOURNAL ARTICLE REFERENCE: KIM, B-K ET AL. CLINICAL IMPACT OF INTRAVASCULAR ULTRASOUND¿GUIDED CHRONICTOTAL OCCLUSION INTERVENTION WITH ZOTAROLIMUS-ELUTING VERSUS BIOLIMUS-ELUTING STENT IMPLANTATION: RANDOMIZED STUDY. CIRC CARDIOVASC INTERV. 2015;8:E002592. DOI:10.1161/CIRCINTERVENTIONS.115.002592. DATE OF EVENT = DATE JOURNAL ARTICLE WAS ACCEPTED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PATIENT WAS ENROLLED IN A COMPARISON STUDY BETWEEN IVUS-GUIDED GROUP AND THE ANGIO-GUIDED GROUP. DURING THE INDEX PROCEDURE THE PATIENT HAD ONE RESOLUTE INTEGRITY DRUG ELUTING STENT IMPLANTED IN THE LCX. APPROX 10 DAYS POST INDEX PROCEDURE, THE PATIENT SUFFERED AN MI AND DEFINITE STENT THROMBOSIS. THE PATIENT VISITED THE ER PRESENTING WITH CHEST PAIN AFTER DISCHARGE, ECG CHANGE AND CARDIAC ENZYME ELEVATION. A CORONARY ANGIOGRAM WAS PERFORMED. FLOW WAS SLOW AND A FILLING DEFECT SUGGESTIVE OF THROMBI AND DISSECTION OF THE DISTAL STENT EDGE WERE NOTED. THE PROCEDURE WAS STOPPED BECAUSE OF SMALL VESSEL SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387433 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization