BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2052334 · Received April 12, 2011

    Report

    Report Number
    2134265-2011-01197
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 17, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). 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. 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 REPORT #: 2134265-2011-01183. (B)(4). IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED IN-STENT RESTENOSIS. THE INDEX PROCEDURE TREATED A 70% STENOSED, BIFURCATED LESION OF THE MID AND DISTAL LAD (LEFT ANTERIOR DESCENDING) MEASURING 2.5X22MM. TREATMENT CONSISTED OF DIRECT STENTING USING A 2.5X24MM TAXUS LIBERTE STENT AND POST DILATION RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL. IN (B)(6) 2011, THE PATIENT PRESENTED WITH CHEST PAIN ASSOCIATED WITH SHORTNESS OF BREATH ON EXERTION. A STRESS TEST SHOWED APICAL LATERAL ISCHEMIA AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE PROXIMAL LAD WAS TREATED WITH BALLOON ANGIOPLASTY USING A 2.5X15MM QUANTUM MAVERICK BALLOON, PLACEMENT OF A 2.75X18MM PROMUS STENT, AND POST DILATION RESULTING IN 0% RESIDUAL STENOSIS. FOLLOWING INFLATION OF THE 2.5X15MM QUANTUM MAVERICK BALLOON THERE WAS SOME WATERMELON SEEDING BACKWARDS ON THE FIRST INFLATION. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893624250 13090952

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention