BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 3063495 · Received April 17, 2013

    Report

    Report Number
    2134265-2013-02354
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 19, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6). 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

    PER THE CEC ADJUDICATION STENT THROMBOSIS OCCURRED.

    Description of Event or Problem · 1

    (B)(4) CLINICAL STUDY. SAME CASE AS MDR ID# 2134265-2012-02353; SAME CASE AS MDR ID# 2134265-2012-02355; SAME CASE AS MDR ID# 2134265-2012-02356. SAME CASE AS MDR ID# 2134265-2012-02357 IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, JAILING OF A VESSEL AND A MYOCARDIAL INFARCTION OCCURRED. (B)(6) 2010 - THE PATIENT PRESENTED WITH MID-STERNAL CHEST PAIN RADIATING UP TO THE NECK, DESCRIBED AS "BURNING PAIN" AND ASSOCIATED WITH SYMPTOM OF SHORTNESS OF BREATH WHICH WORSENED ON MINIMAL EXERTION DIAGNOSED WITH STABLE ANGINA. THE PATIENT HAD TWO LESIONS TREATED DURING THE PROCEDURE, TARGET LESION #1 WAS A DE-NOVO LESION, LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 95% STENOSIS AND WAS 16 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00 MM. WHICH WAS TREATED WITH DIRECT STENT PLACEMENT USING A 3.00 X12 MM TAXUS LIBERTE STENT OVERLAPPING DISTALLY WITH A 2.75 X 8 MM TAXUS LIBERTE STENT, WITH 9% RESIDUAL STENOSIS. TARGET LESION #2 WAS A DE-NOVO LONG LESION, LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY (LCX) AND EXTENDING TO THE 1ST OBTUSE MARGINAL (OM) WITH 95% STENOSIS AND WAS 40 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM. WHICH WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.75 X 12 MM TAXUS LIBERTE STENT OVERLAPPING DISTALLY WITH 2.75 X 32 MM, WITH 9% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL. (B)(6) 2013 - THE PATIENT PRESENTED WITH COMPLAINTS OF SEVERE SUB-STERNAL CHEST PAIN ASSOCIATED WITH SYMPTOMS OF ARM PAIN, CHEST PRESSURE, JAW PAIN, NAUSEA, NECK PAIN, SWEATS AND WEAKNESS AND WAS HOSPITALIZED ON THE SAME DAY. THE PATIENT WAS DIAGNOSED WITH ST ELEVATION MYOCARDIAL INFARCTION. A 100% STENOSIS LOCATED IN THE PROXIMAL LAD AND EXTENDING TO THE MID LAD, JUST PROXIMAL AND IN TANDEM WITH THE PREVIOUSLY PLACED TAXUS LIBERTE STENTS IN MID LAD, WAS TREATED WITH BALLOON ANGIOPLASTY USING A 3.00 X 20 MM EMERGE BALLOON, FOLLOWED BY DEPLOYMENT OF A 3.50 X 18 MM NON BSC STENT. FOLLOWING THIS, A DISSECTION WAS NOTED IN MID LAD. THE DISSECTION WAS TREATED WITH THE PLACEMENT OF ANOTHER 2.50 X 22 MM NON BSC STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS LESS THAN 10%. THE PATIENT WAS DISCHARGED THREE DAYS LATER ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164533 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H749389378270 13382334

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention