BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1841601 · Received September 22, 2010

    Report

    Report Number
    2134265-2010-04470
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    April 19, 2010
    Report Date
    September 21, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).DEVICE IS 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). SAME CASE AS MFR REPORT #: 2134265-2010-04471. SAME PATIENT AS MFR REPORT #: 2134265-2010-04472. IT WAS REPORTED THAT FOLLOWING A STENTING TREATMENT PROCEDURE, THE PATIENT PRESENTED WITH IN STENT RESTENOSIS. IN (B)(6)2008, A NON STUDY STENTING PROCEDURE TREATED THE 90% STENOSED TARGET LESION LOCATED BETWEEN THE MID AND PROXIMAL LEFT CIRCUMFLEX (LCX) ARTERY. TREATMENT PLACED A PLANNED 2.75X16MM TAXUS EXPRESS2 STENT. IT WAS NOTED THAT A VESSEL DISSECTION REQUIRING INTERVENTION OCCURRED. A 2.75X8MM TAXUS EXPRESS2 STENT WAS PLACED IN THE PROXIMAL LCX ARTERY, WHICH WAS LIKELY BEING USED FOR BAILOUT TREATMENT. POST DILATION WAS PERFORMED WITH A MAVERICK2 BALLOON RESULTING IN 0% RESIDUAL STENOSIS. IN (B)(6)2010, THE PATIENT PRESENTED WITH CHEST PAIN AND WAS HOSPITALIZED. A 90% IN STENT RESTENOSIS OF THE LCX WAS REVEALED. TREATMENT PLACED A PROMUS STENT AND UTILIZED POST DILATION RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED FOUR DAYS LATER.

    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 H7493897008270 0011092751

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R 2.75X16MM TAXUS EXPRESS2