BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 3000421 · Received March 12, 2013

    Report

    Report Number
    2134265-2013-01248
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    August 16, 2012
    Report Date
    February 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RETURNED. 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).

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH, PATIENT SEX, RELEVANT TESTS/LAB DATA, OTHER RELEVANT HISTORY: UPDATED.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION (MI). THE LESION BEING TREATED WAS LOCATED IN THE 2ND OBTUSE MARGINAL. THE PHYSICIAN IMPLANTED A TAXUS LIBERTE STENT OF UNKNOWN SIZE. IN (B)(6) 2012, THE PATIENT EXPERIENCED A MI. THE PATIENT WAS HOSPITALIZED. IN (B)(6) 2012, THE 100% STENOSIS OF THE 1ST OBTUSE MARGINAL MEASURING 3.0X35MM WS TREATED WITH A NON-BSC STENT. RESIDUAL STENOSIS WAS 0%.

    Description of Event or Problem · 1

    SAME CASE AS MDR 2134265-2013-04419. IT WAS FURTHER REPORTED THAT DURING THE INDEX PROCEDURE THE 100% STENOSED , 3.0X48MM DE NOVO TARGET LESION WAS TREATED WITH PREDILATION, PLACEMENT OF A 2.5X20 TAXUS LIBERTE AND 3.0X32MM TAXUS LIBERTE STENTS AND POSTDILATION. RESIDUAL STENOSIS WAS 0% AND TIMI FLOW WAS RESTORED TO 3. THE PATIENT WAS DISCHARGED ON ASPIRIN AND TICLOPIDINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103567 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization