BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM

    MDR report key: 2982978 · Received February 28, 2013

    Report

    Report Number
    2134265-2013-01033
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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 MDR ID # 2134265-2013-01032. IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, THROMBOSIS OCCURRED. THE PATIENT WAS PRESENTED WITH A THROMBOTIC LESION IN THE MILDLY CALCIFIED RIGHT CORONARY ARTERY (RCA). THE VESSEL WAS ASPIRATED. THE VESSEL WAS PRE-DILATED AND PROMUS ELEMENT MONORAIL 3.50X24MM WAS DELIVERED AT 12 ATM OVER A NON-BSC GUIDE WIRE TO MID RCA. NC QUANTUM APEX BALLOON CATHETER 4.5MM WAS ADVANCED WITH SOME DIFFICULTY AND THE STENT WAS POST DILATED. STENT DEFORMATION WAS IDENTIFIED IN THE MID STENT. VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM 4.5MM WAS DELIVERED TO COVER THE STENT DEFORMATION. POST DILATION WAS PERFORMED AND THE RESULTS WERE SATISFACTORY. AFTER FEW HOURS THE THROMBOSIS WAS IDENTIFIED IN THE STENT. ASPIRATION AND POST DILATATION WERE PERFORMED AND VERIFLEX STENTS WERE PLACED AT BOTH THE PROXIMAL AND DISTAL ENDS OF THE PROMUS ELEMENT MONORAIL 3.50X24MM STENT. THE RESULTS WERE SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88247 VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE UNK208

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention