BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 3131770 · Received May 29, 2013

    Report

    Report Number
    2134265-2013-03658
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. 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

    (B)(4). SAME CASE AS MDR ID: 2134265-2013-03659. IT WAS REPORTED THAT POST PERCUTANEOUS CORONARY INTERVENTION, CHEST PAIN OCCURRED. IN (B)(6) 2010, THE SUBJECT PRESENTED WITH STABLE ANGINA AND CARDIAC CATHETERIZATION WAS RECOMMENDED. TARGET LESION #1 WAS A DE-NOVO LESION LOCATED IN THE PROXIMAL RCA WITH 90 % STENOSIS AND WAS 11 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM. TARGET LESION #1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.75 MM X 16 MM AND 3.00 MM X 8 MM OVERLAPPING STENTS. FOLLOWING POST DILATATION RESIDUAL STENOSIS WAS 0%. ON (B)(6) 2013, THE SUBJECT PRESENTED WITH CHEST PAIN AND INTERVENTION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235381 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H749389368300 13382622

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention