BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 7590802 · Received June 12, 2018

    Report

    Report Number
    2134265-2018-04979
    Event Type
    Injury
    Date Received
    June 12, 2018
    Report Date
    May 14, 2018
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: HAMSHERE, STEPHEN ET AL. (2018). RANDOMISED TRIAL OF THE COMPARISON OF DRUG-ELUTING STENTS IN PATIENTS WITH DIABETES: OCT DES TRIAL. OPEN HEART 2018;5:E000705. DOI: 10.1136/OPENHRT-2017-000705. DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE INVESTIGATION CONCLUSION IS ANTICIPATED PROCEDURAL COMPLICATION AS THE EVENT IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE DIRECTIONS FOR USE, AND/OR DEVICE LABELING. (B)(4)

    Description of Event or Problem · 1

    SAME LITERATURE ARTICLE AS 2134265-2018-05337. REPORTED VIAL JOURNAL ARTICLE IT WAS REPORTED THAT MYOCARDIAL INFARCTION, THROMBOSIS AND IN-STENT RESTENOSIS (ISR) OCCURRED. THE AIM OF THE STUDY WAS TO ASSESS THE DEGREE OF NEOINTIMAL STENT COVERAGE IN SECOND GENERATION DRUG ELUTING STENTS (DES) IN A DIABETIC POPULATION AND TO ASSESS THE CLINICAL AND ANGIOGRAPHIC OUTCOMES OF SECOND GENERATION DES. PATIENTS WERE RANDOMIZED TO RECEIVE EITHER A PROMUS ELEMENT DRUG ELUTING STENT OR ANOTHER MANUFACTURERS DRUG ELUTING STENT. INTRACORONARY OCT (OPTICAL COHERENCE TOMOGRAPHY) WAS PERFORMED 6 MONTHS POST-PROCEDURE. SIGNIFICANT ISR BY OCT WAS DEFINED BY >50% OF THE DIAMETER STENOSIS IN THE STENTED REGION. ANALYSIS INCLUDED STENT MAL-APPOSITION DEFINED AS STRUTS WITH DETACHMENT FROM THE VESSEL. AT SIX MONTHS POST PROCEDURE OCT WAS PERFORMED AND SIGNIFICANT ISR WAS SEEN IN 15% (9) PATIENTS WITH NO SIGNIFICANT DIFFERENCE SEEN IN RATES OF SIGNIFICANT ISR OR SYMPTOMS BETWEEN THE TWO STENT TYPES. THE OVERALL INCIDENCE OF MACE RATES WAS 8.2% WITH THE CAUSE BEING NON-ST ELEVATION MYOCARDIAL INFARCTION REQUIRING REINTERVENTION. ONE INCIDENCE WAS ST-ELEVATION MYOCARDIAL INFARCTION SECONDARY TO INCOMPLETE STENT EXPANSION THAT RESULTED IN STENT THROMBOSIS 3 DAYS POST STENT DEPLOYMENT. MAL-APPOSED STENT STRUTS WERE OBSERVED IN BOTH STENT TYPES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435617 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY UNK634

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention