BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2110205 · Received June 1, 2011

    Report

    Report Number
    2134265-2011-02104
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    January 11, 2011
    Report Date
    May 3, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. PATIENT IDENTIFIER: (B)(6). DEVICE EVALUATED BY MFR: 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

    (B)(4). SAME CASE AS MFR ID#: 2134265-2011-02105. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, STENT THROMBOSIS OCCURRED. THE PATIENT PRESENTED AT THE TIME OF THE INDEX PROCEDURE WITH UNSTABLE ANGINA. CARDIAC CATHETERIZATION REVEALED 2 TARGET LESIONS. THE FIRST WAS A 70-85% STENOSED AND 48MM LONG BIFURCATED LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD) WITH A REFERENCE VESSEL DIAMETER OF 2.75MM. IT WAS NOTED THAT THIS WAS IN STENT RESTENOSIS OF AN UNSPECIFIED STENT IN THE MID LAD. IT WAS TREATED WITH PREDILATION AND PLACEMENT OF A 2.75X38MM TAXUS LIBERTE STENT AND POST DILATION RESULTING IN 0% RESIDUAL STENOSIS. THE SECOND WAS A 70% STENOSED AND 48MM LONG BIFURCATED LESION LOCATED IN THE DISTAL LAD WITH A REFERENCE VESSEL DIAMETER OF 2.75MM. IT WAS TREATED WITH PREDILATION AND PLACEMENT OF A 2.75X12MM TAXUS LIBERTE STENT AND POST DILATION RESULTING IN 0% RESIDUAL STENOSIS. AT THIS TIME, THE OSTIUM OF THE DIAGONAL BRANCH WAS TREATED WITH BALLOON ANGIOPLASTY RESULTING IN 10% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED 1 DAY LATER ON ASPIRIN AND PRASUGREL. (B)(6) 2011: THE PATIENT PRESENTED AT A FOLLOW UP VISIT WITH CHEST PAIN AND DYSPNEA. CARDIAC CATHETERIZATION REVEALED 70% IN STENT RESTENOSIS OF THE LAD STUDY STENT THAT WAS REPORTED TO BE STENT THROMBOSIS. THIS WAS TREATED WITH A 2.75X28MM VERIFLEX BARE METAL STENT RESULTING IN 0% RESIDUAL STENOSIS. THE EVENT IS REPORTED TO BE RESOLVED WITH RESIDUAL EFFECTS, AND THE PATIENT WAS DISCHARGED 1 DAY LATER. IT IS THE OPINION OF THE PHYSICIAN THAT THIS EVENT IS UNRELATED TO THE TAXUS LIBERTE STENTS.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT AT THE TIME OF THE EVENT, THE PATIENT HAD AN ABNORMAL STRESS TEST AND WAS DIAGNOSED AS HAVING RECURRENT ANGINA.

    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 - MAPLE GROVE UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention 2.75X12MM TAXUS LIBERTE STENT