BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1993567 · Received February 16, 2011

    Report

    Report Number
    2134265-2011-00209
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    September 25, 2010
    Report Date
    January 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MANUFACTURER - THE COMPLAINT DEVICE WAS NOT 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) CLINICAL STUDY. SAME CASE AS: 2134265-2011-00210. IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED SYNCOPE AND A ARRHYTHMIA.. THE TARGET LESION BEING TREATED WAS LOCATED IN THE PROXIMAL AND MID LEFT ANTERIOR DESCENDING ARTERY. THE 90% STENOSED TARGET LESION WAS 3.0MM IN DIAMETER AND 25MM LONG. THE TARGET LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF A 3.0X24MM AND 3.0X12MM TAXUS LIBERTE STENTS. POST DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 0%. A SIDE BRANCH OCCLUSION WAS NOTED. AN INTRAVASCULAR ULTRASOUND (IVUS) WAS UNABLE TO CROSS BEYOND THE PROXIMAL SEGMENT OF THE RIGHT CORONARY ARTERY(RCA) DUE TO SEVERE CALCIFICATION. TREATMENT OF THE RCA WAS NOT ATTEMPTED DUE TO CONTRAST USED. IT WAS NOTED THAT DURING THE PROCEDURE THE PATIENT EXPERIENCED AN ANTERIOR Q-WAVE MYOCARDIAL INFARCTION WITH NEW ST SEGMENT DEPRESSION. THE INVESTIGATOR FELT THIS WAS NOT RELATED TO THE TAXUS STENTS. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS. THE PATIENT WAS DISCHARGED 4 DAYS LATER ON ASPIRIN AND PRASUGREL. A 24 DAYS POST PROCEDURE, THE SITE REPORTED THE PATIENT EXPERIENCED NEAR SYNCOPE SECONDARY TO VENTRICULAR TACHYCARDIA/VENTRICULAR FIBRILLATION. THE PATIENT WAS TREATED WITH CARDIOVERSION VIA AICD. THE EVENT 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 H7493893624300 13040569

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention 3.0X12MM TAXUS LIBERTE STENT