BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 7590707 · Received June 12, 2018

    Report

    Report Number
    2134265-2018-05337
    Event Type
    Malfunction
    Date Received
    June 12, 2018
    Report Date
    May 14, 2018
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    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 . (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME LITERATURE ARTICLE AS 2134265-2018-04979. 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 MALAPPOSITION 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. MALAPPOSED STENT STRUTS WERE OBSERVED IN BOTH STENT TYPES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434258 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY UNK634

    Patients

    Seq Age Sex Outcome Treatment
    1