BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 3030157 · Received April 2, 2013

    Report

    Report Number
    2134265-2013-01982
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 4, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED 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. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN. (B)(6) 2010 - THE PATIENT WAS DIAGNOSED WITH UNSTABLE ANGINA. THE 80% STENOSED, DE NOVO TARGET LESION WAS LOCATED IN DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND WAS 1.4 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.40 MM. WHICH WAS TREATED WITH DIRECT STENT PLACEMENT USING A 3.00 X 16 MM TAXUS LIBERTE STENT, WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL. (B)(6) 2013 - THE PATIENT PRESENTED WITH CHEST PAIN, ADMITTED TO THE HOSPITAL AND TREATED WITH MEDICATION.

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT DIRECT STENTING OCCURRED DURING (B)(6) 2010 PROCEDURE BUT HAS BEEN SINCE CORRECTED TO PRE-DILATATION WITH AN UNKNOWN BALLOON CATHETER. IT WAS ALSO FURTHER REPORTED THAT IN (B)(6) 2013, THE PATIENT WAS DIAGNOSED WITH INTERMEDIATE CORONARY SYNDROME WHICH WAS TREATED MEDICALLY. FOUR DAYS LATER, THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134126 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893716300 13329386

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention