BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 3052919 · Received April 11, 2013

    Report

    Report Number
    2134265-2013-02450
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    January 22, 2013
    Report Date
    March 14, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    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

    IT WAS FURTHER REPORTED THAT IN (B)(6) 2010 THE 90% STENOSED LESION WAS PREDILATED WITH A 2.75MM BALLOON CATHETER. THE 3.50X24MM TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND COULD NOT CROSS THE LESION. PREDILATION WAS AGAIN PERFORMED WITH A 3.25MM BALLOON CATHETER. THE 3.50X24MM TAXUS LIBERTE SDS WAS AGAIN ADVANCED AND DEPLOYED COVERING THE OSTIUM AND DISTAL LEFT MAIN CORONARY ARTERY AND THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. POST-DILATION WAS THEN PERFORMED WITH A 4.00MM BALLOON CATHETER. THE STENOSIS WAS REDUCED TO 10 PERCENT. THE PATIENT WAS DISCHARGED ON 325MG OF ASPIRIN AND 75MG OF CLOPIDOGREL. IN (B)(6) 2013 THE CT SCAN SHOWED NO ACUTE ABNORMALITIES. AT THE TIME OF THE EVENT, THE PATIENT WAS TAKING ASPIRIN AND WAS NON-COMPLIANT WITH THE DUAL ANTIPLATELET THERAPY. NO TREATMENT WAS PERFORMED FOR THE TRANSIENT ISCHEMIC ATTACK (TIA) REQUIRED NO TREATMENT, AND THERE WERE NO RESIDUAL DEFICITS. THE EVENT WAS CONSIDERED RESOLVED WITHIN 24 HOURS. THE TIA WAS NOT RELATED TO THE STENT OR STENTING PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE TRANSIENT ISCHEMIC ATTACK OCCURRED. AN UNSPECIFIED SIZE TAXUS LIBERTE STENT WAS DEPLOYED IN AUGUST 2010. IN (B)(6) 2013 THE PATIENT RETURNED WITH SLURRED SPEECH AND A CT SCAN WAS PERFORMED. THE SLURRED SPEECH LASTED LESS THAN 24 HOURS. A TRANSIENT ISCHEMIC ATTACK WAS DIAGNOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154717 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other