BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2062784 · Received April 19, 2011

    Report

    Report Number
    2134265-2011-01203
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 21, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT PATIENT IDENTIFIER - (B)(6). DEVICE EVALUATED BY MANUFACTURER - THE COMPLAINT DEVICE WAS NOT RETURNED 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

    (B)(4). SAME CASE AS: 2134265-2011-01204. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED RESTENOSIS. DURING THE INDEX, THE TARGET LESION BEING TREATED WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS 90% STENOSED, 3.0MM IN DIAMETER AND 26MM LONG. THE LESION WAS TREATED WAS PREDILATION AND PLACEMENT OF A 3.0X32MM PERSEUS WH STENT. RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED 1 DAY LATER ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2010, IT WAS NOTED THAT THE PATIENT EXPERIENCED CORONARY ARTERY STENOSIS. THE LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD), WAS TREATED WITH THE PLACEMENT OF AN UNKNOWN SIZE TAXUS LIBERTE STENT. THE LESION LOCATED IN THE 1ST DIAGONAL WAS TREATED WITH THE PLACEMENT OF AN UNKNOWN SIZE TAXUS LIBERTE STENT. IN (B)(6) 2011, IT WAS NOTED THAT THE PATIENT EXPERIENCED RESTENOSIS. THE LESIONS LOCATED IN THE PROXIMAL LAD AND 1ST DIAGONAL WERE TREATED WITH PLACEMENT OF AN UNKNOWN SIZE TAXUS LIBERTE AND PROMUS STENTS. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PROCEDURE WAS RESOLVED WITHOUT RESIDUAL EFFECTS.

    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 - MAPLE GROVE UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention