BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 2894975 · Received January 3, 2013

    Report

    Report Number
    2134265-2012-08300
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    June 17, 2011
    Report Date
    December 6, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER DEVICE EVALUATION BY MANUFACTURER: 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

    (B)(6). SAME PATIENT AS: 2134265-2010-04931. SAME CASE AS: 2134265-2012-08301. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, A MYOCARDIAL INFARCTION OCCURRED. THE PATIENT UNDERWENT THE INDEX PROCEDURE IN (B)(6) 2010 DUE TO A POSITIVE STRESS TEST. CARDIAC CATHETERIZATION REVEALED A LESION IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD). A 3.0 X 16 MM TAXUS LIBERTE STENT DELIVERY SYSTEM WAS ADVANCED AND DEPLOYED IN THE TARGET LESION, AT WHICH POINT AN UNKNOWN GRADE EDGE DISSECTION OCCURRED. IT WAS TREATED WITH PLACEMENT OF A 2.5 X 8 MM TAXUS LIBERTE STENT RESULTING IN 0% RESIDUAL STENOSIS AND TIMI-3 FLOW. THE DISSECTION WAS REPORTED TO BE RESOLVED. THERE WAS ALSO AN UNSPECIFIED DRUG ELUTING STENT PLACED IN THE RIGHT CORONARY ARTERY (RCA). THE PATIENT WAS DISCHARGED THE NEXT DAY ON CLOPIDOGREL. IN (B)(6) 2011 A MYOCARDIAL INFARCTION OCCURRED. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND EPISODES OF CHEST HEAVINESS. TEST RESULTS REVEALED 80% STENOSIS IN MID RCA PROXIMAL TO PREVIOUS STENT, AND 90% STENOSIS IN LAD PROXIMAL TO PREVIOUS STENT. THE PATIENT WAS REFERRED FOR ENDOSCOPIC ATRAUMATIC CORONARY ARTERY BYPASS (ENDO-ACAB) SURGERY TO TREAT THE LESION IN THE LAD AND PERCUTANEOUS CORONARY INTERVENTIONAL (PCI) TREATMENT OF THE LESION IN THE RCA. DURING SURGERY THE LEFT INTERNAL MAMMARY ARTERY WAS ANASTOMOSED TO THE LAD. LATER THE SAME DAY THE PATIENT HAD A PCI TREATMENT PROCEDURE DEPLOYING A 3.0 X 12 ION MR DRUG ELUTING STENT AT 14 ATMS IN THE 5 MM LONG, 80% STENOSED TARGET LESION IN THE MID RIGHT CORONARY ARTERY (RCA) OVERLAPPING THE PREVIOUS STENT. RESIDUAL STENOSIS WAS 0%. A TEMPORARY PACEMAKER WAS ALSO PLACED. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS DISCHARGED ON PLAVIX FOR 1 YEAR AND ASPIRIN TO BE TAKEN INDEFINITELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2604 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893616300 12976289

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention