BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2023770 · Received March 18, 2011

    Report

    Report Number
    2134265-2011-01043
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    April 21, 2010
    Report Date
    February 24, 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 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).

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2011-04410. (B)(6). IT WAS REPORTED THAT FOLLOWING A STENTING TREATMENT PROCEDURE, THE PATIENT PRESENTED WITH RESTENOSIS. THE INDEX PROCEDURE TREATED THE 99% STENOSED, 3.0X40MM TARGET LESION LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX (LCX) ARTERY. TREATMENT PLACED TWO OVERLAPPING TAXUS LIBERTE STENTS (2.5X32MM, 3.0X12MM) RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2010, WITH NO ISCHEMIC SYMPTOMS THE PATIENT UNDERWENT ANGIOGRAPHY REVEALING A 75% STENOSED, 3.0X18MM LESION LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX (LCX) ARTERY. TREATMENT UTILIZED BALLOON ANGIOPLASTY AND PLACED A NON BSC STENT RESULTING IN 0% RESIDUAL STENOSIS. A LESION LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY WAS ALSO TREATED WITH BALLOON ANGIOPLASTY AND THE PLACEMENT OF A NON-BSC STENT. THE OUTCOME WAS LISTED AS "RESOLVED" AND THE PATIENT WAS DISCHARGED THE NEXT DAY. PER THE PHYSICIAN, THE EVENT WAS LISTED AS "POSSIBLY RELATED" TO THE STUDY STENT. NO ANGINA WAS CONFIRMED AT THE 9 MONTH AND 1 YEAR STUDY FOLLOW UP VISITS.

    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 H7493893612300

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention 2.5X32MM TAXUS LIBERTE