BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 2936124 · Received January 30, 2013

    Report

    Report Number
    2134265-2013-00167
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    December 28, 2012
    Report Date
    January 2, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RECEIVED 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

    SAME CASE AS MFR: 2134265-2013-00136 & 2134265-2013-00161. (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED, UNSTABLE ANGINA. IN (B)(6) 2010, THE PATIENT PRESENTED WITH UNSTABLE ANGINA. THE FIRST TARGET LESION WAS 99% STENOSED AND 50MM IN LENGTH LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) EXTENDING TO THE MID RCA WITH A REFERENCE DIAMETER OF 3.50MM. THIS WAS TREATED WITH PRE-DILATION AND PLACEMENT OF A 4.00 X 20 MM (PROXIMAL) AND A 3.50 X 38 MM (DISTAL) TAXUS LIBERTE STENTS. FOLLOWING POST-DILATION, THE RESIDUAL STENOSIS WAS 0%. THE SECOND LESION WAS 75% STENOSED AND 20MM IN LENGTH LOCATED IN THE RIGHT POSTERIOR DESCENDING ARTERY (PDA) WITH A REFERENCE DIAMETER OF 3.00MM. THIS WAS TREATED WITH PRE-DILATION AND PLACEMENT OF A 2.75 X 16 MM TAXUS LIBERTE STENT. FOLLOWING POST-DILATION THE RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2010, THE PATIENT EXPERIENCED NON-EXERTIONAL CARDIAC CHEST PAIN IN (B)(6) 2011, THE PATIENT EXPERIENCED NON-CARDIAC CHEST PAIN. IN (B)(6) 2012, THE PATIENT WAS DIAGNOSED WITH UNSTABLE ANGINA. THE PATIENT UNDERWENT OUTPATIENT CATHETERIZATION WITH NO INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41179 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493893620400 12261297

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other