BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 3844003 · Received June 2, 2014

    Report

    Report Number
    2134265-2014-02961
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    April 24, 2014
    Report Date
    May 6, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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

    (B)(4). IT WAS REPORTED THAT ANGINA, DYSPNEA ON EXERTION AND IN-STENT RESTENOSIS (ISR) OCCURRED. ON (B)(6) 2010, THE PATIENT PRESENTED WITH COMPLAINTS OF IRREGULAR HEARTBEAT, DIZZINESS WITH CHANGE OF POSITION. ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH UNSTABLE ANGINA AND CARDIAC CATHETERIZATION WAS RECOMMENDED. SUBSEQUENTLY, CORONARY ANGIOGRAPHY AND THE INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS A DE-NOVO LESION LOCATED IN THE DISTAL SAPHENOUS VEIN GRAFT (SVG) TO 2ND OBTUSE MARGINAL (OM) WITH 95% STENOSIS AND WAS 10MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.6MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 X 12MM TAXUS® LIBERTÉ® STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. THE TARGET LESION #2 WAS A DE-NOVO LESION LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX (LCX) WITH 90% STENOSIS AND WAS 15MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.6MM. THE TARGET LESION #2 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 X 20 MM TAXUS® LIBERTÉ® STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. ON (B)(6) 2014, THE PATIENT PRESENTED WITH COMPLAINTS OF TWO WEEKS CHEST TIGHTNESS, WORSENING SHORTNESS OF BREATH, AND DYSPNEA ON EXERTION. CARDIAC CATHETERIZATION WAS SCHEDULED ON A LATER DATE. ON (B)(6) 2014, THE PATIENT PRESENTED WITH INCREASING SEVERE EXERTIONAL DYSPNEA, INCREASING CHEST DISCOMFORT WITH EXERTION AND ABNORMAL NUCLEAR STRESS TEST. THE PATIENT WAS DIAGNOSED WITH ANGINA AND WAS HOSPITALIZED ON THE SAME DAY. AT THE TIME OF EVENT, THE PATIENT WAS ON ASPIRIN ONLY. THE STUDY DRUG PER PROTOCOL WAS LAST TAKEN ON (B)(6) 2013 AND OTHER ANTIPLATELET MEDICATION WAS NEVER TAKEN DURING THE STUDY. SUBSEQUENTLY, CORONARY ANGIOGRAPHY WAS PERFORMED. THE 90% ISR OF STUDY STENT PLACED IN PROXIMAL LCX WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A 3.00 X 20MM PROMUS PREMIER MR STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. IN ADDITION, NON TARGET VESSEL REVASCULARIZATION (TVR) WAS PERFORMED IN PROXIMAL RIGHT CORONARY ARTERY (RCA), WHICH WAS TREATED WITH BALLOON ANGIOPLASTY. THE PATIENT WAS ALSO TREATED MEDICALLY. ONE DAY POST PROCEDURE, THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321508 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893620250 13040564

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R