BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1565884 · Received December 15, 2009

    Report

    Report Number
    2134265-2009-07202
    Event Type
    Injury
    Date Received
    December 15, 2009
    Date of Event
    August 31, 2009
    Report Date
    December 4, 2009
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING PROCEDURE, THE PATIENT EXPERIENCED IN-STENT RESTENOSIS. THE TARGET LESION WAS LOCATED IN THE DISTAL LCX, L-AV PER CORE LAB, WITH 90% STENOSIS, A LENGTH OF 16.0 MM AND REFERENCE VESSEL DIAMETER OF 2.75 MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.75 X 20 MM TAXUS EXPRESS2 STUDY STENT WITH 0% RESIDUAL STENOSIS. A NON-TARGET LESION IN THE PROXIMAL LAD WAS TREATED WITH A TAXUS EXPRESS2 DURING THE INDEX PROCEDURE. THE PATIENT WAS DISCHARGED 2 DAYS LATER ON ASPIRIN AND CLOPIDOGREL. ON 545 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED WITH LEFT-SIDED CHEST PRESSURE RADIATING TO HIS BACK ASSOCIATED WITH PRE-SYNCOPE AND DIAPHORESIS. CLOPIDOGREL HAD BEEN STOPPED FOR THREE DAYS THE PREVIOUS WEEK FOR A DENTAL PROCEDURE. THE DISTAL LCX WAS TREATED WITH CUTTING BALLOON ANGIOPLASTY AND A 2.75 X 23 MM NON BSC STENT WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC 2.75X20MM 97995990

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R