BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM

    MDR report key: 3897045 · Received June 26, 2014

    Report

    Report Number
    2134265-2014-03780
    Event Type
    Injury
    Date Received
    June 26, 2014
    Date of Event
    February 26, 2014
    Report Date
    May 30, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. 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 MDR ID: 2134265-2014-03052, 2134265-2014-03050, 2134265-2014-03781, 2134265-2014-03782. (B)(4) (B)(6) 2012, THE PATIENT WAS DIAGNOSED WITH UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE 90% STENOSED AND 15MM LONG TARGET LESION WAS IN-STENT RESTENOSIS OF AN UNKNOWN MANUFACTURER¿S DRUG ELUTING SENT LOCATED IN THE MID SAPHENOUS VEIN GRAFT (SVG) TO THE RIGHT POSTERIOR DESCENDING ARTERY (R-PDA) WITH A REFERENCE VESSEL DIAMETER OF 4MM. THE TARGET LESION WAS TREATED WITH DIRECT STENT PLACEMENT OF A 4.0X16MM AND 4.0X20MM ION STENT, RESULTING IN 0% RESIDUAL STENOSIS. THE FOLLOWING DAY THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. (B)(6) 2014, THE PATIENT PRESENTED WITH THE SYMPTOMS OF SHORTNESS OF BREATH ASSOCIATED WITH SWEATING, NAUSEA, SUB STERNAL CHEST PAIN RADIATING TOWARDS NECK AND JAW AND WAS HOSPITALIZED ON THE SAME DAY. THE PATIENT¿S CARDIAC ENZYMES WERE FOUND TO BE ELEVATED AND THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION AND EXPERIENCED ISCHEMIC SYMPTOMS. THE FOLLOWING DAY A 100% TOTALLY OCCLUDED STENT THROMBOSIS WAS NOTED TO THE OF THE PREVIOUSLY PLACED NON STUDY STENTS (4.5MM LIBERTE STENT, 4.0X12MM PROMUS STENT, 3.5X18MM PROMUS, 4.00X18MM, PROMUS STENT, 4X16MM ION STENT AND 4X12MM ION STENT) AND STUDY STENTS LOCATED IN R-PDA WERE TREATED WITH BALLOON ANGIOPLASTY, RESULTING IN 0% RESIDUAL STENOSIS. ADDITIONALLY THE SAME DAY THE PATIENT WAS DIAGNOSED WITH FRONTAL LOBE CVA. EIGHT DAYS AFTER THE ONSET OF SYMPTOMS, THE EVENTS WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON PLAVIX AND ASPIRIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374911 VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE UNK208

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention