BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS (R) LIBERTÉ (R)

    MDR report key: 2032750 · Received March 29, 2011

    Report

    Report Number
    2134265-2011-01078
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    March 15, 2010
    Report Date
    March 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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

    SAME CASE AS MFR ID#: 2134265-2011-03339, 2134265-2011-03340 IT WAS FURTHER REPORTED THAT AT THE TIME OF THE INDEX PROCEDURE, THE PATIENT PRESENTED DUE TO STABLE ANGINA (CCS CLASS I) AND THAT THERE WAS TIMI-1 FLOW PRE TREATMENT. CARDIAC CATHETERIZATION REVEALED A NEW LESION THAT WAS VISUALLY 100% STENOSED (71% PER CORE LAB ANALYSIS) WITH A REFERENCE VESSEL DIAMETER OF 3.5MM LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY. IT WAS TREATED WITH PREDILATION AND PLACEMENT OF 3.0X28MM, 3.5X28MM AND 3.5X24MM TAXUS LIBERTE STENTS WITH GAP AND POST DILATION RESULTING IN 0% RESIDUAL STENOSIS (16% PER CORE LAB ANALYSIS). TIMI FLOW IMPROVED TO 3. THE PATIENT WAS DISCHARGED 3 DAYS LATER ON ASPIRIN AND CLOPIDOGREL BISULFATE. AT THE TIME OF THE EVENT, THE PATIENT UNDERWENT DIAGNOSTIC CARDIAC CATHETERIZATION, AND INTERVENTION 11 DAYS LATER. FOLLOWING TREATMENT, CORE LAB ANALYSIS OF THE VESSEL INDICATES THAT THERE WAS 42% RESIDUAL STENOSIS. TIMI FLOW IMPROVED FROM 0 TO 3.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, RESTENOSIS OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) AND WAS TREATED WITH PLACEMENT OF AN UNKNOWN SIZE TAXUS LIBERTE STENT ON AN UNKNOWN DATE. (B)(6) 2010: THE PATIENT UNDERWENT WENT CARDIAC CATHETERIZATION WHICH REVEALED 25% STENOSIS IN THE PROXIMAL RCA WITH A REFERENCE VESSEL DIAMETER OF 3.5MM AND 100% STENOSIS OF THE RIGHT POSTERIOR ATRIOVENTRICULAR (PAV) CORONARY ARTERY WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. NO ISCHEMIC SYMPTOMS WERE PRESENT. THE PHYSICIAN REPORTED A POSSIBLE RELATIONSHIP BETWEEN THE TAXUS LIBERTE STUDY STENT AND THE RESTENOSIS IN THE RIGHT PAV. THE LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF A NON-BSC DRUG ELUTING STENT RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT'S CONDITION WAS REPORTED TO HAVE "IMPROVED" THE SAME DAY AND THE PATIENT WAS DISCHARGED 2 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS (R) LIBERTÉ (R) CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493893628300

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R