BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1944329 · Received January 3, 2011

    Report

    Report Number
    2134265-2010-05916
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    July 1, 2010
    Report Date
    December 6, 2010
    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 A 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

    (B)(6) STUDY. IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT REQUIRED TARGET VESSEL REVASCULARIZATION. THE PATIENT WAS INITIALLY TREATED WITH AN UNKNOWN SIZE TAXUS LIBERTE STENT. THE TARGET LESION BEING TREATED WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD). IN (B)(6) 2010, THE PATIENT EXPERIENCED A POSITIVE STRESS TEST. A FOLLOW-UP CORONARY ANGIOGRAM WAS PERFORMED FOR THE LESION LOCATED IN THE PROXIMAL LAD. THE LESION WAS 99% STENOSED, 3.0MM IN DIAMETER AND 10MM LONG. THE PATIENT UNDERWENT A TARGET VESSEL REVASCULARIZATION WITH THE PLACEMENT OF A NON-BSC STENT. RESIDUAL STENOSIS WAS 0%. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S OUTCOME IS IMPROVED. IN (B)(6) 2010, A 1 YEAR FOLLOW-UP WAS PERFORMED. THE PATIENT HAD NO ANGINAL SYMPTOMS.

    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