BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2003030 · Received February 28, 2011

    Report

    Report Number
    2134265-2011-00647
    Event Type
    Injury
    Date Received
    February 28, 2011
    Date of Event
    December 21, 2010
    Report Date
    February 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). 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

    (B)(6). IT WAS REPORTED THAT FOLLOWING A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION (MI). THE INDEX PROCEDURE TREATED THE 100% STENOSED, 2.5X22MM TARGET LESION LOCATED IN THE 3RD OBTUSE MARGINAL BRANCH WITH TIMI 0 FLOW. TREATMENT CONSISTED OF PRE DILATION AND THE PLACEMENT OF A 2.5X20MM TAXUS LIBERTE STUDY STENT RESULTING IN 0% RESIDUAL STENOSIS AND TIMI 3 FLOW. POST THE INDEX PROCEDURE AND PRIOR TO DISCHARGE THE PATIENT HAD ELEVATED ENZYMES THAT MET THE PROTOCOL DEFINITION OF AN MI. NO ACTION WAS TAKEN AND THE SUBJECT WAS DISCHARGED LATER THE SAME DAY ON ASPIRIN AND PRASUGREL. PER THE PHYSICIAN, THE EVENT WAS LISTED AS "RELATED" TO THE STUDY STENT.

    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 - GALWAY H7493893628220 12795511

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other