BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2123911 · Received June 14, 2011

    Report

    Report Number
    2134265-2011-02202
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 17, 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

    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. 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

    IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE THROMBOSIS OCCURRED. THE 90% STENOSED, 3.0X16MM TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS PREDILATED AND THEN A 2.0X16MM TAXUS LIBERTE STENT WAS DEPLOYED IN LEFT ANTERIOR DESCENDING ARTERY (LAD). IT WAS NOTED THAT THE STENT DID NOT FULLY EXPAND. THE LESION WAS POSTDILATED AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS PUT ON ASPIRIN AND CLOPIDOGREL. ONE YEAR AND SIX MONTHS LATER, DURING A FOLLOW UP PROCEDURE, STENT THROMBOSIS IN THE PROXIMAL AND DISTAL END OF THE STENT WAS OBSERVED. TO TREAT THE THROMBOSIS, A NON BSC STENT WAS DEPLOYED IN THE PROXIMAL END OF THE STENT AND A PROMUS STENT WAS DEPLOYED IN THE DISTAL END OF THE TAXUS LIBERTE STENT. IVUS WAS PERFORMED AND THE PROCEDURE WAS COMPLETED. AN UNSPECIFIED AMOUNT OF TIME LATER, DURING A FOLLOW-UP APPOINTMENT, THROMBOSIS WAS DISCOVERED IN THE NON BSC STENT AND THE PROMUS STENT THAT WERE USED TO TREAT THE TAXUS LIBERTE IN-STENT RESTENOSIS. THE PATIENT DID NOT DISPLAY ANY SYMPTOMS AND TREATMENT WAS NOT PERFORMED ON THE THROMBOSIS, IT WAS NOTED THAT THE TREATMENT WILL BE PERFORMED AT A LATER DATE. NO ADDITIONAL 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