BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1171178 · Received September 22, 2008

    Report

    Report Number
    2134265-2008-02759
    Event Type
    Injury
    Date Received
    September 22, 2008
    Date of Event
    June 29, 2007
    Report Date
    August 27, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT 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

    SAME CASE AS MFR REPORT #: 2134265-2080-02758, 2134265-2008-02760, 2134265-2008-02761. CLINICAL STUDY. IT WAS REPORTED 384 DAYS FOLLOWING A CORONARY ARTERY STENTING PROCEDURE THAT THE PATIENT RETURNED WITH IN-STENT RESTENOSIS. THE INDEX PROCEDURE TREATED THE DE NOVO, 100% STENOSED 3X48MM LESION LOCATED IN THE PROXIMAL AND MID PORTIONS OF THE LAD (LEFT ANTERIOR DESCENDING) ARTERY. TREATMENT CONSISTED OF PRE-DILATION, PLACEMENT OF FOUR OVERLAPPING TAXUS EXPRESS2 DRUG ELUTING STENTS (3.0X8MM, (2) 2.5X24MM AND 3.0X28MM) AND POST DILATION RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT RETURNED 384 DAYS FOLLOWING THE INDEX PROCEDURE FOR A STUDY REQUIRED 13 MONTH ANGIOGRAM. THE PATIENT WAS ASYMPTOMATIC HOWEVER ANGIOGRAPHY REVEALED AN 80% IN-STENT RESTENOSIS IN ONE OF THE 2.5X24MM STENTS IMPLANTED IN THE MID-LAD ARTERY CONFIRMED BY IVUS. REINTERVENTION CONSISTED OF BALLOON ANGIOPLASTY. PATIENT HAS MEDICATION HISTORY OF ASPIRIN AND PLAVIX. THE EVENT WAS LISTED AS RESOLVED AND THE INVESTIGATOR ASSESSED THE EVENT AS RELATED TO THE DEVICE. THERE WERE NO FURTHER ADVERSE EVENTS FOR THE PATIENT.

    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 CORPORATION 3.00X8MM 7780564

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention