BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 6567438 · Received May 15, 2017

    Report

    Report Number
    2134265-2017-04857
    Event Type
    Injury
    Date Received
    May 15, 2017
    Report Date
    April 25, 2017
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: (B)(6) 2016, IF IMPLANTED, GIVE DATE: (B)(6) 2004. DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT ANGINA AND IN-STENT RESTENOSIS (ISR) OCCURRED. IN (B)(6) 2016, CLINICAL STATUS ASSESSMENT INDICATED THAT THE PATIENT 'S QUALIFYING CONDITION AS STABLE ANGINA AND THE INDEX PROCEDURE WAS PERFORMED. TARGET LESION #1 WAS AN ISR OF A PREVIOUSLY PLACED TAXUS STENT AND AN UNKNOWN STENT LOCATED IN THE 1ST DIAGONAL BRANCH WITH 80% STENOSIS AND WAS 6 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. TARGET LESION #1 WAS TREATED WITH DIRECT PLACEMENT OF A 2.50 X 12 MM SYNERGY STUDY STENT AND RESIDUAL STENOSIS WAS 0%. TARGET LESION #2 WAS LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 80% STENOSIS AND WAS 6 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25 MM. TARGET LESION #2 WAS TREATED WITH DIRECT PLACEMENT OF A 2.25 X 12 MM SYNERGY STUDY STENT AND RESIDUAL STENOSIS WAS 0%. ON THE SAME DAY, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY (ASPIRIN AND CLOPIDOGREL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347683 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY UNK432

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention