BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 3023952 · Received March 27, 2013

    Report

    Report Number
    2134265-2013-01841
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    December 5, 2011
    Report Date
    March 4, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. PATIENT IDENTIFIER: (B)(6). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    SAME PATIENT AS MDR ID# 2134265-2013-01845. SAME PATIENT AS MDR ID# 2134265-2013-01699. (B)(4) STUDY. IT WAS REPORTED THAT POST A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, IN-STENT RESTENOSIS OCCURRED. (B)(6) 2011 THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION WAS IN-STENT RESTENOSIS OF THE PREVIOUSLY PLACED TAXUS LIBERTE STENT THAT WAS PLACED IN (B)(6) 2010. THE 95% STENOSIS AND 16MM LONG TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITH A REFERENCE VESSEL DIAMETER OF 2.8MM. THE IN-STENT RESTENOSIS WAS TREATED WITH DIRECT STENT PLACEMENT OF A 2.50X20MM ION STENT, RESULTING IN 0% RESIDUAL STENOSIS. THE FOLLOWING DAY THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126532 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention