BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1994232 · Received February 17, 2011

    Report

    Report Number
    2134265-2011-00344
    Event Type
    Injury
    Date Received
    February 17, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 20, 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. 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

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE TAXUS LIBERTE STENTS WERE PLACED IN (B)(6) 2009 AND ON AN UNKNOWN DATE. THE LESION WAS BIFURCATED, 75% STENOSED WITH A REFERENCE VESSEL DIAMETER OF 2.5MM FOR THE CIRCUMFLEX AND 3.0MM FOR THE LAD. THE CIRCUMFLEX LESION WAS LESS THAN 30MM LONG AND THE LAD LESION WAS LESS THAN 60MM LONG. PREDILATION, POST DILATION, AND IVUS (INTRAVASCULAR ULTRASOUND) POST STENTING WERE PERFORMED. THE PATIENT WAS REPORTED TO BE TAKING ASPIRIN FROM (B)(6) 2009 UNTIL AN UNKNOWN DATE AND CLOPIDOGREL FROM (B)(6) 2009 TO (B)(6) 2010. THE THROMBOSIS WAS IN-STENT THROMBOSIS. IVUS POST THROMBECTOMY SHOWED PROPER INTIMAL GROWTH WITH NO RESIDUAL STENOSIS. THE PATIENT WAS HOSPITALIZED ON A "WAIT AND SEE" APPROACH, THE PATIENT'S CONDITION WAS GOOD AND THE PATIENT WAS DISCHARGED IN (B)(6) 2011.

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2011-00342, 2134265-2011-00343. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT DEVELOPED STENT THROMBOSIS. THE PATIENT HAD THREE TAXUS LIBERTE STENTS OF UNKNOWN SIZE PLACED. ONE IN THE CIRCUMFLEX (LCX) AND TWO IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). APPROXIMATELY 18 MONTHS LATER THE PATIENT DEVELOPED SHOCK AND WAS TRANSPORTED TO THE HOSPITAL BY AMBULANCE. ANGIOGRAPHY SHOWED COMPLETE OCCLUSION OF THE STENTS IN THE LCX, LAD, AND 1ST DIAGONAL. THROMBECTOMY WAS PERFORMED AND BLOOD FLOW IMPROVED. POST INTERVENTION INTRAVASCULAR ULTRASOUND (IVUS) SHOWED NO STENOSIS WITHIN THE STENTS AND THE INNER MEMBRANE WAS IN GOOD CONDITION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention