BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM

    MDR report key: 3100504 · Received May 8, 2013

    Report

    Report Number
    2134265-2013-03339
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 10, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE COMPLAINT DEVICE WAS NOT RECEIVED 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 MDR ID # 34265-2013-03343, MDR ID # 2134265-2013-03373, MDR ID# 2134265-2013-03372. (B)(4). IT WAS REPORTED THAT POST PERCUTANEOUS CORONARY INTERVENTION, THE PATIENT EXPERIENCED UNSTABLE ANGINA. A NON-STUDY VERIFLEX BARE METAL STENT WAS IMPLANTED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) IN (B)(6) 2012. IN (B)(6) 2013, THE PATIENT PRESENTED WITH UNSTABLE ANGINA AND WAS HOSPITALIZED ON THE SAME DAY. THE PATIENT UNDERWENT CARDIAC CATHETERIZATION WHICH REVEALED A 50 TO 70% IN-STENT RESTENOSIS OF PREVIOUSLY PLACED VERIFLEX BARE METAL STENT IN THE RIGHT CORONARY ARTERY (RCA). A KINETIX ANGIOPLASTY WIRE WAS ADVANCED INTO THE DISTAL RCA AND A 2.75 X 32 MM PROMUS DRUG ELUTING STENT WAS PLACED. THEN, A 3.00 X 15 MM QUANTUM NONCOMPLIANT BALLOON CATHETER WAS USED FOR POST DILATATION OF THE LESION. A SPASM WAS THEN NOTED AT THE DISTAL VESSEL AND WAS TREATED WITH INTRACORONARY NITROGLYCERIN. ON THE SAME DAY THE EVENT WAS CONSIDERED RESOLVED AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201380 VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE UNK208

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention