BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2981574 · Received February 27, 2013

    Report

    Report Number
    2134265-2013-00924
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER - DEVICE NOT RETURNED; THEREFORE, ANALYSIS OF COMPLAINT DEVICE COULD NOT BE PERFORMED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR ID # 2134265-2013-00938. IT WAS REPORTED THAT FOLLOWING A PERCUTANEOUS CORONARY INTERVENTION, THE PATIENT EXPERIENCED MYOCARDIAL INFARCTION AND THROMBUS. THE 99% STENOSED, TYPE C TARGET LESION WAS LOCATED CIRCUMFLEX (CX) ARTERY AND OBTUSE MARGINAL (OM) BIFURCATION WITH TIMI FLOW 0-1. THE LESION WAS PRE-DILATED WITH A 3.25X20MM QUANTUM APEX BALLOON. THE 3.0X24MM PROMUS ELEMENT AND 2.75X16MM PROMUS ELEMENT STENTS WERE SUCCESSFULLY IMPLANTED IN THE 2ND OBTUSE MARGINAL ARTERY (OM). THE 2ND OM ARTERY WAS ALSO TREATED WITH BALLOON ANGIOPLASTY. THROMBECTOMY WAS ALSO PERFORMED WITH AN ASPIRATION CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DISCHARGED. FIVE DAYS POST INDEX PROCEDURE PATIENT WAS HOSPITALIZED WITH ST SEGMENT ELEVATION MYOCARDIAL INFARCTION AND IN-STENT THROMBUS. THE CX WAS BALLOONED WITH A 3.0X15MM MAVERICK BALLOON, AND THE 2ND OM WAS BALLOONED WITH A 2.25X12MM MAVERICK BALLOON. FOLLOWING BALLOON ANGIOPLASTY TIMI 3 FLOW WAS RESTORED. THE PHYSICIAN STATED THAT THE PATIENT WAS NOT COMPLIANT NOT TAKING HIS ANTI-PLATELET THERAPY. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83432 PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY UNK717

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention BALLOON CATHETER: 3.25X20MM QUANTUM