BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM

    MDR report key: 3892434 · Received June 24, 2014

    Report

    Report Number
    2134265-2014-03515
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    January 23, 2014
    Report Date
    May 27, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2014-03516. (B)(4) STUDY. IT WAS REPORTED THAT ANGINA, MYOCARDIAL INFARCTION (MI) AND IN-STENT RESTENOSIS (ISR) OCCURRED. ON UNSPECIFIED DATE, A 3.0MM X 16MM LIBERTE BARE METAL STENT WAS IMPLANTED AT THE PROXIMAL LEFT CIRCUMFLEX ARTERY (LCX). ON (B)(6) 2014, THE PATIENT WAS PRESENTED WITH A HISTORY OF THREE TO FOUR MONTHS OF PROGRESSIVE ANGINA PECTORIS AND CORONARY ARTERY DISEASE. SUBSEQUENTLY, PATIENT WAS HOSPITALIZED. THE PATIENT¿S CARDIAC ENZYMES WERE FOUND TO BE ELEVATED AND MI OCCURRED. ELECTROCARDIOGRAM (ECG) REVEALED NON Q WAVE MI. IT WAS OBSERVED THAT THE PATIENT EXPERIENCED ISCHEMIC SYMPTOMS. FOLLOWING DAY, CORONARY ANGIOGRAPHY REVEALED 100% IN-STENT OCCLUSION OF SVG TO FIRST DIAGONAL. SIX DAYS FROM THE ONSET OF SYMPTOMS, THE OCCLUSION IN DISTAL RIGHT CORONARY ARTERY (RCA) WAS TREATED WITH PLACEMENT OF 3.0 MM X 12 MM PROMUS PREMIER DRUG ELUTING STENT AND THE 80% IN-STENT RESTENOSIS OF THE MID LEFT CIRCUMFLEX (LCX) (OF THE PREVIOUSLY PLACED 3 MM X 16 MM LIBERTE BARE METAL STENT) WAS TREATED WITH 2.75 MM X 16 MM PROMUS PREMIER DRUG ELUTING STENT. MEDICATION WAS GIVEN TO TREAT THE EVENT. TWO DAYS POST PROCEDURE, THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367635 VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE UNK208

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R