BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2032282 · Received March 29, 2011

    Report

    Report Number
    2134265-2011-00973
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    May 13, 2010
    Report Date
    February 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. PATIENT IDENTIFIER: (B)(6). DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED 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)(4). SAME CASE AS MFR ID#: 2134265-2011-00972, 2134265-2011-00974. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, RESTENOSIS OCCURRED. THE PATIENT PRESENTED DUE TO SILENT ISCHEMIA AND WAS REFERRED FOR CARDIAC CATHETERIZATION WHICH REVEALED 2 TARGET LESIONS. THE FIRST WAS AN 80% STENOSED AND 10MM LONG LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD) WITH A REFERENCE VESSEL DIAMETER OF 2.25MM. IT WAS TREATED WITH PREDILATION AND PLACEMENT OF A 2.25X12MM TAXUS LIBERTE STENT RESULTING IN 0% RESIDUAL STENOSIS. THE SECOND LESION WAS LOCATED IN THE FIRST OBTUSE MARGINAL (OM1) AND WAS TREATED WITH A 2.5X24MM TAXUS EXPRESS2 STENT AND A 2.75X20MM TAXUS EXPRESS2 STENT. THE PATIENT WAS DISCHARGED 1 DAY LATER ON ASPIRIN AND PLAVIX. (B)(6) 2010, THE PATIENT PRESENTED WITH EXERTIONAL DYSPNEA AND ANGINA. A NUCLEAR STRESS TEST INDICATED ISCHEMIA IN THE RIGHT CORONARY AND LAD DISTRIBUTION. CARDIAC CATHETERIZATION REVEALED THE SEVERE IN STENT RESTENOSIS OF THE LAD AND OM1. THE MID LAD WAS TOTALLY OCCLUDED. THIS WAS TREATED WITH SUCCESSFUL BALLOON ANGIOPLASTY OF THE MID LAD IN STENT RESTENOSIS VIA THE LEFT INTERNAL MAMMARY ARTERY (LIMA) GRAFT. ATTEMPTS WERE MADE TO DELIVER A 2.5X13MM NON BSC DRUG ELUTING STENT BUT DUE TO SEVERE TORTUOUSITY OF THE LIMA GRAFT AND LACK OF VESSEL SUPPORT, WAS UNABLE TO BE PLACED. A DECISION WAS MADE TO STOP THE PROCEDURE AFTER SEVERAL ATTEMPTS WITH PLANS TO RETURN WITH ACCESS VIA THE LEFT BRACHIAL ARTERY. 1 DAY LATER, THE PATIENT RETURNED AND UNDERWENT SUCCESSFUL ANGIOPLASTY AND STENT IMPLANTATION TO THE RIGHT POSTERIOR DESCENDING ARTERY (RPDA) AND LEFT CIRCUMFLEX (LCX). THE RPDA WAS TREATED WITH 2 NON-BSC DRUG ELUTING STENTS (3.5X13MM AND 3.5X8MM) RESULTING IN 0% RESIDUAL STENOSIS AND THE LCX WAS TREATED WITH 4 DRUG ELUTING STENTS (2.5X13MM, 3.5X33MM, 3.5X12MM AND 4.0X8MM) RESULTING IN 10% RESIDUAL STENOSIS. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED 4 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 - MAPLE GROVE UNK432

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R 2.25X12MM TAXUS LIBERTE ATOM STENT| 2.75X20MM TAXUS EXPRESS2 STENT