BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2142488 · Received June 28, 2011

    Report

    Report Number
    2134265-2011-02714
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    July 21, 2010
    Report Date
    June 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. PATIENT IDENTIFIER - (B)(6). IF IMPLANTED, GIVE DATE : 2007. 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 POST A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED RESTENOSIS. AN UNSPECIFIED TAXUS EXPRESS2 STENT WAS IMPLANTED IN THE PROXIMAL CIRCUMFLEX (CX). IN (B)(6) 2010 THE PATIENT PRESENTED WITH STABLE ANGINA AND CARDIAC CATHETERIZATION WAS PERFORMED. CORONARY ANGIOGRAPHY REVEALED A NEW LESION AT THE OSTIUM OF CX AND IN-STENT RESTENOSIS OF A PREVIOUSLY PLACED TAXUS EXPRESS STENT IN THE PROXIMAL PORTION OF THE CX. LESION 1 WAS LOCATED IN THE PROXIMAL CIRCUMFLEX (CX). THE LESION WAS 80% STENOSED, 3.0MM IN DIAMETER AND 10MM LONG. THE LESION WAS TREATED WITH DIRECT STENTING WITH A 3.0X12MM TAXUS LIBERTE STENT. POST DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 10%. LESION 2 WAS LOCATED IN THE PROXIMAL CIRCUMFLEX (CX). THE LESION WAS 70% IN-STENT RESTENOSIS OF THE TAXUS EXPRESS2 STENT, 3.0MM IN DIAMETER AND 28MM LONG. THE LESION WAS TREATED WITH DIRECT STENTING WITH A 3.0X38MM TAXUS LIBERTE STENT. POST DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 10%. THE PATIENT WAS DISCHARGED 1 DAY LATER ON ASPRIN AND PRASUGREL.

    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 UNK432

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention