BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2111169 · Received June 2, 2011

    Report

    Report Number
    2134265-2011-02103
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    February 24, 2011
    Report Date
    May 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(4). DEVICE IS A COMBINATION PRODUCT. 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

    SAME CASE AS MFR REPORT #: 2134265-2011-01966. (B)(4) CLINICAL TRIAL. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT DEVELOPED IN-STENT RESTENOSIS. THE INDEX PROCEDURE TREATED FOUR TARGET LESIONS. TARGET LESION ONE WAS A 2.5X23MM, 95% STENOSIS OF THE 2ND OM (OBTUSE MARGINAL). TARGET LESION ONE WAS TREATED WITH PREDILATION, PLACEMENT OF A 2.25X24MM TAXUS LIBERTE STENT, AND POST DILATION RESULTING IN 0% RESIDUAL STENOSIS. TARGET LESION TWO WAS A 2.5X7MM, 75% STENOSIS OF THE 2ND OM. TARGET LESION TWO WAS TREATED WITH PREDILATION, PLACEMENT OF A 2.5X8MM TAXUS LIBERTE STENT, AND POST DILATION RESULTING IN 0% RESIDUAL STENOSIS. TARGET LESION THREE WAS A 2.5X26MM, 95% STENOSIS OF THE 1ST DIAGONAL. TARGET LESION THREE WAS TREATED WITH PREDILATION, PLACEMENT OF A 2.25X28MM TAXUS LIBERTE STENT, AND POST DILATION RESULTING IN 0% RESIDUAL STENOSIS. TARGET LESION FOUR WAS A 2.5X11MM, 75% STENOSIS OF THE 1ST DIAGONAL. TARGET LESION FOUR WAS TREATED WITH PREDILATION, PLACEMENT OF A 2.5X12MM TAXUS LIBERTE STENT, AND POST DILATION RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS SCHEDULED TO RETURN FOR A STAGED PROCEDURE OF THE RCA (RIGHT CORONARY ARTERY) AND WAS DISCHARGED ONE DAY POST PROCEDURE ON ASPIRIN AND PRASUGREL. THE FOLLOWING MONTH, THE PATIENT RETURNED FOR TREATMENT OF A FIFTH TARGET LESION MEASURING 3.5X12MM WITH 80% STENOSIS OF THE DISTAL RCA. TARGET LESION FIVE WAS TREATED WITH PREDILATION, PLACEMENT OF A 4.0X12MM TAXUS LIBERTE STENT, AND POST DILATION RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS AGAIN DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2011, THE PATIENT WAS ADMITTED DUE TO CARDIAC CHEST PAIN. CATHETERIZATION REVEALED AN 85% IN-STENT RESTENOSIS OF THE OSTIAL 1ST DIAGONAL STENT WITH THE STENT IN THE MID 1ST DIAGONAL PATENT. TREATMENT CONSISTED OF ANGIOPLASTY AND PLACEMENT OF A 2.5X8MM PROMUS STENT RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED ONE DAY LATER ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893728220 12816364

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R