BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1941443 · Received December 29, 2010

    Report

    Report Number
    2134265-2010-05758
    Event Type
    Injury
    Date Received
    December 29, 2010
    Date of Event
    April 13, 2010
    Report Date
    December 6, 2010
    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. 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 BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    TAXUS LIBERTE (B)(4) POST MARKET SURVEILLANCE STUDY. IT WAS REPORTED THAT FOLLOWING A STENTING TREATMENT PROCEDURE, THE PATIENT PRESENTED WITH IN STENT RESTENOSIS. THE INDEX PROCEDURE PLACED AN UNSPECIFIED TAXUS LIBERTE STENT IN THE MID RIGHT CORONARY ARTERY (RCA). IN (B)(6) 2010, AT THE 9 MONTH STUDY FOLLOW UP, ANGIOGRAPHY REVEALED RESTENOSIS IN THE MID RCA AND STENOSIS IN THE PROXIMAL RCA. TREATMENT THE NEXT DAY PLACED AN UNSPECIFIED PROMUS STENT IN THE 90% RESTENOSED, 3.50X10MM TARGET LESION LOCATED IN THE MID RCA RESULTING IN 0% RESIDUAL STENOSIS AND TIMI 3 FLOW. TREATMENT PLACED A 3.5X12MM PROMUS STENT IN THE 90% STENOSED, 3.50X12MM LESION FOUND IN THE PROXIMAL RCA RESULTING IN 0% RESIDUAL STENOSIS AND TIMI 3 FLOW. THE PATIENT OUTCOME WAS LISTED AS "IMPROVED" THE SAME DAY.

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2011-01044. IT WAS FURTHER REPORTED THAT 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 3.5X20MM TAXUS LIBERTE STENTS AND POST DILATION RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED TWO DAYS LATER ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2010, AT THE REVASCULARIZATION 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".

    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 - GALWAY H7493893620350

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R 3.5X32 TAXUS LIBERTE