BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1920249 · Received December 10, 2010

    Report

    Report Number
    2134265-2010-05538
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    February 5, 2010
    Report Date
    November 15, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS A 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)(4). IT WAS REPORTED THAT FOLLOWING A STENTING TREATMENT PROCEDURE, THE PATIENT PRESENTED WITH IN STENT RESTENOSIS. THE INDEX PROCEDURE TREATED THE 99% STENOSED, 2.25X10MM TARGET LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY. TREATMENT CONSISTED OF PRE-DILATION AND THE PLACEMENT OF A 2.25X16MM TAXUS LIBERTE STENT RESULTING IN 0% RESIDUAL STENOSIS. A 90% STENOSED, 2.5X10MM NON-TARGET LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WAS TREATED WITH A 2.5X12 TAXUS EXPRESS2 STENT. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2010, THE PATIENT PRESENTED WITH UNSTABLE ANGINA AND WAS HOSPITALIZED. A REINTERVENTION PROCEDURE THE SAME DAY REVEALED A 90% STENOSIS WITH TIMI 2 FLOW IN THE PROXIMAL RCA. TREATMENT PLACED AN UNSPECIFIED PROMUS STENT RESULTING IN 0% RESIDUAL STENOSIS AND TIMI 3 FLOW. THE NEXT DAY THE EVENT RESOLVED WITH NO RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493897012250 7902568

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R