BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ® ATOM¿

    MDR report key: 2905045 · Received January 9, 2013

    Report

    Report Number
    2134265-2012-08412
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    July 14, 2010
    Report Date
    December 13, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(6). DEVICE EVALUATION 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 PATIENT AS MDR ID# 2134265-2012-06774, 2134265-2012-06775 AND 2134265-2012-06776. (B)(4) STUDY. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, JAILING OCCURRED. THE 90% STENOSED AND 14MM LONG DE-NOVO FIRST TARGET LESION WAS LOCATED IN THE 3RD OBTUSE MARGINAL WITH A REFERENCE VESSEL DIAMETER OF 2.25 MM. THE FIRST TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2 (2.25X12 MM) TAXUS LIBERTE STENTS IN AN OVERLAPPING MANNER, RESULTING IN 0% RESIDUAL STENOSIS. THE 70% STENOSED AND 2.25MM LONG DE-NOVO SECOND TARGET LESION WAS LOCATED IN THE MIDDLE LEFT ANTERIOR DESCENDING ARTERY WITH A REFERENCE VESSEL DIAMETER OF 8 MM. THE SECOND TARGET LESION WAS TREATED WITH DIRECT STENT PLACEMENT USING A 2.25X12 MM TAXUS LIBERTE STENT, RESULTING IN 0% RESIDUAL STENOSIS FOLLOWING POST. FOLLOWING STENT DEPLOYMENT THERE WAS JAILING OF 2ND DIAGONAL NOTED WHICH TREATED USING 2.0 X8MM NON BSC BALLOON. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE FOLLOWING DAY THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11059 TAXUS® LIBERTÉ® ATOM¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893612220 0013224196

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention