BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1982832 · Received February 9, 2011

    Report

    Report Number
    2134265-2011-00295
    Event Type
    Injury
    Date Received
    February 9, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 14, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS A COMBINATION PRODUCT. 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

    (B)(4). IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN. IN (B)(6) 2009, AN UNKNOWN SIZE, NON-STUDY TAXUS LIBERTE STENT WAS PLACED IN THE MID RCA (RIGHT CORONARY ARTERY). IN (B)(6) 2009, THE PATIENT WAS ENROLLED THE PLATINUM TRIAL AND A 3.5X26MM, 70% STENOSED LESION OF THE 1ST OM (OBTUSE MARGINAL) WAS IDENTIFIED. TREATMENT CONSISTED OF PREDILATION AND PLACEMENT OF A 3.5X32MM STUDY PROMUS ELEMENT STENT RESULTING IN 0% RESIDUAL STENOSIS. ON DISCHARGE ONE DAY POST PROCEDURE THE PATIENT WAS TAKING ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2011, THE PATIENT EXPERIENCED CHEST PAIN WITH SEVERE EXERCISE. NO TREATMENT WAS REPORTED AND THE EVENT IS REPORTED TO BE UNRESOLVED.

    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 79 YR Other