BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2070657 · Received April 27, 2011

    Report

    Report Number
    2134265-2011-01481
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 30, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER - THE COMPLAINT 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

    IT WAS FURTHER REPORTED THAT IN (B)(6) 2011, THE PATIENT PRESENTED TO THE HOSPITAL WITH TYPICAL CRESCENDO ANGINA. THE FEELING WAS DESCRIBED AS SUBSTERNAL CHEST PRESSURE AND PAIN THAT OCCURRED ON EXERTION, WITH INCREASING FREQUENCY. THE PATIENT WAS RELIEVED WITH NITROGLYCERIN. A LEFT HEART CATHETERIZATION WAS PERFORMED REVEALING 99% STENOSIS AT THE MID RCA, 60-70% STENOSIS AT THE PROXIMAL LAD, AND 90% STENOSIS OF THE 2ND OM BRANCH. IN MARCH 2011, THE CK= 549 UNITS/L (NORMAL RANGE: 26-192 UNITS/L), CK-MB= 38 NG/ML (NORMAL RANGE: 0-3 NG/ML), AND TROPONIN T= 0.69 (UNITS AND NORMAL RANGE NOT PROVIDED). THE ANGINA WAS RELIEVED POST PROCEDURE.

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS: 2131265-2011-01480, 2131265-2011-01479, 2131265-2011-01482. IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED CORONARY ARTERY DISEASE. DURING THE INDEX PROCEDURE, THE PATIENT UNDERWENT THE DEPLOYMENT OF FOUR TAXUS LIBERTE STENTS. THE LESIONS BEING TREATED WERE LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD), 1ST OBTUSE MARGINAL (OM), PROXIMAL RIGHT CORONARY ARTERY (RCA) AND THE MID RCA. THE LESION LOCATED IN THE DISTAL LAD WAS TREATED WITH THE PLACEMENT OF A 2.25X32MM TAXUS LIBERTE STENT, THE 1ST OM WAS TREATED WITH A 2.25X8MM TAXUS LIBERTE STENT, THE PROXIMAL RCA WAS TREATED WAS A 2.25X32MM TAXUS LIBERTE AND THE MID RCA WAS TREATED WITH A 2.25X16MM TAXUS LIBERTE STENT. POST-PROCEDURE RESIDUAL STENOSIS IN DISTAL LAD AND 1ST OM WAS 0%. POST-PROCEDURE RESIDUAL STENOSIS IN THE PROXIMAL AND MID RCA WAS 25%. THE PATIENT BEGAN A 75MG CLOPIDOGREL DOSING. 1 DAY LATER, THE PATIENT BEGAN A 325MM ASPIRIN DOSING. THE PATIENT WAS LATER DISCHARGED. IN (B)(6) 2011, THE PATIENT WAS HOSPITALIZED FOR CORONARY ARTERY DISEASE (CAD). A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED IN THE MID RCA, WITH THE PLACEMENT OF A 2.5X12MM PROMUS STENT. THE PROXIMAL LAD WAS TREATED WITH THE PLACEMENT OF A 4.0X15MM PROMUS STENT. THE OM WAS TREATED WITH PLACEMENT OF A 2.75X12MM PROMUS STENT. THE PATIENT WAS DISCHARGED 1 DAY LATER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention