BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1884293 · Received October 27, 2010

    Report

    Report Number
    2134265-2010-04880
    Event Type
    Injury
    Date Received
    October 27, 2010
    Date of Event
    March 4, 2010
    Report Date
    October 6, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE INDEX PROCEDURE TREATED A DE NOVO, 2.5X20MM, 75% STENOSED LESION OF THE DISTAL CX WITH PREDILATION, PLACEMENT OF A 2.5X20MM TAXUS EXPRESS2 STENT, AND POST DILATION RESULTING IN 0% RESIDUAL STENOSIS. THE DE NOVO, 2.5X23MM, 90% STENOSED OM2 WAS TREATED WITH PRE-DILATION, PLACEMENT OF A 2.5X16MM AND 2.5X12MM TAXUS EXPRESS2 STENTS, AND POST DILATION RESULTING IN 0% RESIDUAL STENOSIS. TIMI 3 FLOW WAS MAINTAINED AT BOTH LESIONS THROUGHOUT THE PROCEDURE. THE PATIENT WAS DISCHARGED SEVEN DAYS POST PROCEDURE ON BAYASPIRIN AND PLAVIX. CORRECTED INFORMATION RECEIVED INDICATED THE REINTERVENTION IN (B)(6) 2010 WAS PERFORMED ON THE DISTAL CX, NOT THE PROXIMAL CX AS PREVIOUSLY REPORTED.

    Description of Event or Problem · 1

    (B)(4). SAME PATIENT AS MFR REPORT #: 2134265-2009-06488. SAME CASE AS MFR REPORT #: 2134265-2010-04881, 2134265-2010-04882. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE THE PATIENT DEVELOPED IN-STENT RESTENOSIS. THE (B)(6) 2008 INDEX PROCEDURE TREATED TWO TARGET LESIONS. ONE IN THE DISTAL CIRCUMFLEX (CX) AND ONE IN THE 2ND OBTUSE MARGINAL (OM2). ONE TAXUS EXPRESS2 STENT WAS PLACED IN THE DISTAL CX AND TWO WERE PLACED IN THE OM2. THE PATIENT EXPERIENCED IN-STENT RESTENOSIS IN (B)(6) 2010. THE PROXIMAL CX HAD A 90% STENOSED, 3.0X12MM LESION. TREATMENT IN (B)(6) 2010 CONSISTED OF ROTATIONAL ATHERECTOMY, BALLOON ANGIOPLASTY, AND PLACEMENT OF AN UNSPECIFIED TAXUS STENT RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED AFTER TWO DAYS. NO ANGINA SYMPTOMS WERE NOTED AT THE (B)(6) 2010 STUDY FOLLOW UP.

    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 - GALWAY H7493897020250 9798510

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R