BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS (R) LIBERTÉ (R)

    MDR report key: 2243661 · Received September 12, 2011

    Report

    Report Number
    2134265-2011-03822
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    December 8, 2010
    Report Date
    August 16, 2011
    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 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. A REVIEW OF THE MANUFACTURING DOCUMENTATION COULD NOT BE PERFORMED AS THE BATCH NUMBER IS UNKNOWN. 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 PATIENT AS MFR REPORT #: 2134265-2010-05758, 2134265-2011-01044. SAME CASE AS MFR REPORT #: 2134265-2011-03821. (B)(4). IT WAS REPORTED THAT FOLLOWING A STENTING TREATMENT PROCEDURE, THE PATIENT PRESENTED WITH IN STENT RESTENOSIS. THE INDEX PROCEDURE TREATED THE 75% STENOSED, 3.5X52MM TARGET LESION LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). TREATMENT CONSISTED OF PRE-DILATION, THE PLACEMENT OF TWO OVERLAPPING TAXUS LIBERTE STENTS (3.5X20MM. 3.5X32MM) AND POST DILATION RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED TWO DAYS LATER ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2010, WITH NO ISCHEMIC SYMPTOM, ANGIOGRAPHY REVEALED RESTENOSIS IN THE MID RCA. THE 63% RESTENOSED, 1.19X26MM LESION FOUND IN THE MID RCA WAS TREATED WITH BALLOON ANGIOPLASTY RESULTING IN 18% RESIDUAL STENOSIS. TIMI 3 FLOW WAS MAINTAINED THROUGH OUT THE PROCEDURE. THE PATIENT OUTCOME WAS LISTED AS "IMPROVED" THE SAME DAY. THE PATIENT WAS DISCHARGED TWO DAYS LATER. PER THE PHYSICIAN, THE EVENT WAS LISTED AS POSSIBLY RELATED TO THE STUDY STENT. IN (B)(6) 2011, AT THE 2 YEAR STUDY FOLLOW UP VISIT THE PATIENT HAD NO ANGINAL SYMPTOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS (R) LIBERTÉ (R) CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493893620350

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention 3.5X12MM PROMUS IN PROXIMAL RCA| 3.5X20 TAXUS LIBERTE IN MID RCA| DRIVER STENT IN PROXIMAL RCA| DRIVER STENT IN MID RCA| 3.5X12MM PROMUS IN MID RCA