BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM

    MDR report key: 2140920 · Received June 27, 2011

    Report

    Report Number
    2134265-2011-02406
    Event Type
    Injury
    Date Received
    June 27, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. 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# 2134265-2011-02407. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE STENT THROMBOSIS OCCURRED AND A VESSEL DISSECTION WAS DISCOVERED. THE PATIENT INITIALLY PRESENTED WITH AN ACUTE MYOCARDIAL INFARCTION AND THROMBUS WAS PRESENT. A 3.0X32MM VERIFLEX STENT WAS IMPLANTED IN THE MID RIGHT CORONARY ARTERY (RCA) AND A 3.0X20MM VERIFLEX WAS IMPLANTED IN THE PROXIMAL RCA, OVERLAPPING THE FIRST PLACED STENT. THE STENTS WERE NOT POSTDILATED. THE STENTS WERE WELL APPOSED IN THE LESION AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT RECEIVED INTEGRILIN. EIGHT DAYS LATER THE PATIENT PRESENTED TO THE EMERGENCY ROOM AND ANGIOGRAPHY DETECTED THROMBOSIS IN THE PREVIOUSLY PLACED STENTS. AN EDGE DISSECTION WAS ALSO NOTED AFTER THE MOST DISTAL, 3.0X32MM STENT. THE THROMBOSIS WAS TREATED WITH AN UNSPECIFIED BALLOON AND TWO 3.0MM ION STENTS WERE PLACED IN THE LESION, TREATING THE STENT THROMBOSIS AND THE DISSECTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CURRENT CONDITION IS FINE. IT WAS NOTED THAT THE PATIENT WAS ON PLAVIX AND IT IS SUSPECTED THAT THE PATIENT DISCONTINUED USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893432300

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention 3.00X20MM VERIFLEX STENT