BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 3864101 · Received June 10, 2014

    Report

    Report Number
    2134265-2014-03252
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    October 12, 2011
    Report Date
    May 13, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS COMBINATION PRODUCT. IF IMPLANTED, GIVE DATE: (B)(6) 2004 . DEVICE EVALUATION 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

    SAME CASE AS 2134265-2014-03134. (B)(4). IT WAS REPORTED POST A STENTING PROCEDURE, IN-STENT RESTENOSIS OCCURRED. (B)(6) 2011 THE PATIENT PRESENTED WITH CHEST PAIN RADIATING TO THE LEFT AND THE PATIENT WAS DIAGNOSED WITH UNSTABLE ANGINA. ANGIOGRAPHY REVEALED A 90% OSTIAL IN-STENT RESTENOSIS OCCURRED WITH THE 32X2.75MM TAXUS STENT PLACED IN THE OM1 WHICH JAILED DUE TO THE 24X3.0MM TAXUS STENT IN THE PROXIMAL LCX. IT WAS NOTED IN MARCH 2004, A 32X2.75MM TAXUS STENT WAS DEPLOYED IN THE 1ST OBTUSE MARGINAL (OM1) ARTERY AND A 24X3.0XX TAXUS STENT WAS DEPLOYED IN THE MID LEFT CIRCUMFLEX (LCX) ARTERY, IN A ¿T-TYPE¿ STENTING TECHNIQUE. THE SAME DAY A 95% STENOSED AND 8MM LONG DE-NOVO TARGET LESION LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH A REFERENCE VESSEL DIAMETER OF 2.75MM. THE TARGET LESION WAS TREATED WITH DIRECT STENT PLACEMENT OF A 12MMX2.75MM TAXUS LIBERTE 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
    338309 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other