BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1833822 · Received September 14, 2010

    Report

    Report Number
    2134265-2010-04306
    Event Type
    Injury
    Date Received
    September 14, 2010
    Date of Event
    March 22, 2010
    Report Date
    August 26, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4). 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)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A VESSEL DISSECTION OCCURRED. THE 90% STENOSED AND 10MM LONG TARGET LESION WAS LOCATED IN THE SECOND OBTUSE MARGINAL (OM) CORONARY ARTERY WITH A REFERENCE VESSEL DIAMETER OF 2.25MM. THE LESION WAS TREATED WITH PREDILATION AND A 2.25X12MM TAXUS LIBERTE ATOM STENT WAS IMPLANTED. FOLLOWING DEPLOYMENT OF THIS STENT, A TYPE "A" DISSECTION WAS NOTED AT THE DISTAL EDGE OF THE SECOND OM. IT WAS TREATED WITH DEPLOYMENT OF A 2.25X8MM TAXUS LIBERTE STENT. FOLLOWING POST DILATION RESIDUAL STENOSIS WAS 0%. A SECOND LESION THAT WAS 90% STENOSED AND 40MM LONG LOCATED IN THE PROXIMAL CIRCUMFLEX ARTERY WITH A REFERENCE VESSEL DIAMETER OF 2.25MM WAS TREATED WITH PREDILATION AND DEPLOYMENT OF 3 TAXUS LIBERTE STENTS, 2.25X12MM, 3.0X16MM AND 2.25X8MM, FOLLOWED BY POST DILATION RESULTING IN 0% RESIDUAL STENOSIS. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED 1 DAY LATER ON ASPIRIN AND PRASUGREL.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A VESSEL DISSECTION OCCURRED. THE 90% STENOSED AND 10MM LONG TARGET LESION WAS LOCATED IN THE SECOND OBTUSE MARGINAL (OM) CORONARY ARTERY WITH A REFERENCE VESSEL DIAMETER OF 2.25MM. THE LESION WAS TREATED WITH PREDILATION AND A 2.25X12MM TAXUS LIBERTE ATOM STENT WAS IMPLANTED. FOLLOWING DEPLOYMENT OF THIS STENT, A TYPE "A" DISSECTION WAS NOTED AT THE DISTAL EDGE OF THE SECOND OM. IT WAS TREATED WITH DEPLOYMENT OF A 2.25X8MM TAXUS LIBERTE STENT. FOLLOWING POST DILATION RESIDUAL STENOSIS WAS 0%. A SECOND LESION THAT WAS 90% STENOSED AND 40MM LONG LOCATED IN THE PROXIMAL CIRCUMFLEX ARTERY WITH A REFERENCE VESSEL DIAMETER OF 2.25MM WAS TREATED WITH PREDILATION AND DEPLOYMENT OF 3 TAXUS LIBERTE STENTS, 2.25X12MM, 3.0X16MM AND 2.25X8MM, FOLLOWED BY POST DILATION RESULTING IN 0% RESIDUAL STENOSIS. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED 1 DAY LATER ON ASPIRIN AND PRASUGREL.

    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 H7493893612220 0013023943

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention 2.25X8MM TAXUS LIBERTE STENT| 3.0X16MM TAXUS LIBERTE STENT| 2.25X12MM TAXUS LIBERTE STENT