BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 2981637 · Received February 27, 2013

    Report

    Report Number
    2134265-2013-01107
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    March 16, 2012
    Report Date
    January 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED 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)(4) STUDY. SAME PATIENT AS MDR ID#: 2134265-2011-00559, 2134265-2011-00560, 2134265-2011-00561, 2134265-2011-00562, 2134265-2011-03341, 2134265-2011-03346, 2134265-2011-03347, 2134265-2011-03348, 2134265-2012-06260, 2134265-2012-06261, 2134265-2012-06262, 2134265-2012-06259. SAME CASE AS MDR ID#: 2134265-2013-01178, 2134265-2013-01106, 2134265-2013-01103, 2134265-2013-01532, 2134265-2013-01533. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, A MYOCARDIAL INFARCTION OCCURRED. INDEX PROCEDURE: (B)(6) 2010 - THE PATIENT PRESENTED DUE TO STABLE ANGINA (CCS CLASS 2) AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THERE WERE 4 TARGET LESIONS IDENTIFIED IN THE LEFT ANTERIOR DESCENDING (LAD) AND RIGHT CORONARY ARTERY (RCA). OF NOTE, THE PATIENT HAD A PREVIOUS CORONARY INTERVENTION IN (B)(6) 2010 WHERE DISEASE IN THESE VESSELS WAS IDENTIFIED AND A DECISION WAS MADE TO TREAT AT A LATER DATE. TARGET LESION #1 WAS 70% STENOSED, 12MM LONG AND LOCATED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD) EXTENDING INTO THE DISTAL LAD WITH A REFERENCE VESSEL DIAMETER OF 2.75MM. IT WAS TREATED WITH PREDILATION AND PLACEMENT OF A 2.75X20MM TAXUS LIBERTE STENT AND POST DILATION RESULTING IN 10% RESIDUAL STENOSIS. TARGET LESION #2 WAS 80% STENOSED, 20MM LONG AND LOCATED IN THE PROXIMAL LAD WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. TARGET LESION #2 WAS TREATED WITH PREDILATION AND PLACEMENT OF A 3.0X38MM TAXUS LIBERTE STENT RESULTING IN 10% RESIDUAL STENOSIS. OF NOTE, THIS LESION WAS REPORTED TO BE IN STENT RESTENOSIS. TARGET LESION #3 WAS 99% STENOSED, 10MM LONG AND LOCATED IN THE DISTAL RCA WITH A REFERENCE VESSEL DIAMETER OF 2.75MM. IT WAS TREATED WITH PREDILATION AND PLACEMENT OF A 2.75X16MM TAXUS LIBERTE STENT AND POST DILATION RESULTING IN 10% RESIDUAL STENOSIS. TARGET LESION #4 WAS 99% STENOSED, 22MM LONG AND LOCATED IN THE PROXIMAL RCA EXTENDING INTO THE MID RCA WITH A REFERENCE VESSEL DIAMETER OF 2.75MM. TREATMENT CONSISTED OF PREDILATION AND PLACEMENT OF A 2.75X28MM TAXUS LIBERTE STENT AND POST DILATION RESULTING IN 10% RESIDUAL STENOSIS. IT WAS REPORTED THAT LAB VALUES SHOWED ELEVATED CARDIAC ENZYMES INDICATING THE PATIENT HAD EXPERIENCED A MYOCARDIAL INFARCTION. NO ACTION WAS TAKEN TO TREAT THIS EVENT. THE NEXT DAY, AN ECG SHOWED NORMAL SINUS RHYTHM AND NO ACUTE CHANGES FROM BASELINE. THE PATIENT WAS THEN DISCHARGED ON ASPIRIN AND PRASUGREL. (B)(6) 2012 - THE PATIENT PRESENTED WITH ATYPICAL LEFT RIB PAIN, CLAUDICATION AND DECLINING RENAL FUNCTION DIAGNOSED WITH NON-ST ELEVATION MYOCARDIAL INFARCTION. AT THE TIME OF THE EVENT, THE PATIENT WAS TAKING ASPIRIN AND OPEN LABEL PRASUGREL. CARDIAC ENZYMES WERE ELEVATED. THE PATIENT WAS TREATED MEDICALLY AND THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS. THE PATIENT WAS DISCHARGED THREE DAYS LATER ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83574 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893616270 13436981

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention