BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 3043469 · Received April 9, 2013

    Report

    Report Number
    2134265-2013-02076
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    November 30, 2010
    Report Date
    March 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS A COMBINATION PRODUCT. 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(4) CLINICAL STUDY. SAME PATIENT AS MDR ID#: 2134265-2010-04770, 2134265-2010-03759, 2134265-2010-03921, 2134265-2010-03922, 2134265-2013-00556, 2134265-2013-00557, 2134265-2013-02066, 2134265-2013-02067. SAME CASE AS MDR ID#: 2134265-2013-02077. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, IN-STENT RESTENOSIS OCCURRED. IN (B)(6) 2010, THE PATIENT PRESENTED WITH ABNORMAL STRESS TEST SUGGESTIVE OF STRESS INDUCED ISCHEMIA. THE PATIENT WAS DIAGNOSED WITH STABLE ANGINA (CCS CLASS 2) AND SILENT ISCHEMIA AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE TARGET LESION WAS LOCATED IN THE 1ST OBTUSE MARGINAL BRANCH (OM1) WITH 90% STENOSIS AND WAS 30MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION AND PLACEMENT OF TWO OVERLAPPING TAXUS LIBERTE STENTS, WITH ONE 3.0X16MM STENT PLACED PROXIMALLY AND ANOTHER 2.5X32MM STENT PLACED DISTALLY, WITH 0% RESIDUAL STENOSIS FOLLOWING POST-DILATION. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2010, THE PATIENT PRESENTED FOR A FOLLOW UP OF THE CORONARY ARTERY DISEASE WITH A POSITIVE STRESS TEST SUGGESTIVE OF STRESS INDUCED ISCHEMIA. THE PATIENT WAS HOSPITALIZED AND CARDIAC CATHETERIZATION WAS RECOMMENDED. IN (B)(6) 2010, IVUS NOTED 75% IN-STENT RESTENOSIS IN THE PROXIMAL OM1, WHICH WAS TREATED WITH BALLOON ANGIOPLASTY AT HIGH PRESSURE. REPEAT IVUS AND ANGIOGRAPHY REVEALED GOOD RESULTS WITH 10% RESIDUAL STENOSIS. IN ADDITION, BEFORE THE TREATMENT OF THE TARGET VESSEL, A NON-TARGET LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (PROX RCA) WAS TREATED WITH CUTTING BALLOON. THE LESION IN THE RIGHT POSTERIOR DESCENDING ARTERY (R-PDA) WAS TREATED WITH PLACEMENT OF A 2.25X16MM TAXUS ATOM STENT WITH THE PROXIMAL PORTION OF THE STENT PLACED IN THE DISTAL RCA. THE PROXIMAL EDGE OF THE STENT WAS POST-DILATED. A 3.00X30MM NON-BSC STENT WAS PLACED IN THE PROXIMAL RCA AND WAS POST-DILATED. FOLLOWING THIS, IVUS INDICATED A SIGNIFICANT LESION IN THE MID RCA WITH 3.9 SQ.MM. LUMINAL AREA. THIS LESION WAS TREATED WITH A 3.00X24MM NON-BSC STENT OVERLAPPING THE FIRST STENT. THE EVENT WAS CONSIDERED TO BE RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED. THE PATIENT WAS ON ASPIRIN AND PRASUGREL BUT NOT ON THE STUDY DRUG DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146000 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493893616300 12894802

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R 2.50X32MM TAXUS LIBERTE STENT