BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1771683 · Received July 27, 2010

    Report

    Report Number
    2134265-2010-03335
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 28, 2010
    Report Date
    June 29, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A 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

    SAME CASE AS MFR# 2134265-2010-03448. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, THROMBOSIS OCCURRED AND THE PATIENT HAD AN STEMI. THE PATIENT PRESENTED TO THE CATH LAB WITH CHEST PAIN THAT RADIATED TO THE LEFT ARM AND AN INFERIOR WALL MYOCARDIAL INFARCTION (MI). ACCESS WAS OBTAINED THROUGH THE RIGHT FEMORAL ARTERY. THE 60-70% STENOSED TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE MID RCA HAD A PREVIOUSLY IMPLANTED STENT WHICH WAS PATENT, HOWEVER AN ADDITIONAL 40-50% TARGET LESION WAS LOCATED IN THE DISTAL RCA. A JR 4.0 GUIDECATHETER ENGAGED WITH VESSEL AND A NON-BSC GUIDEWIRE WAS ADVANCED. NEXT, A 2.25X16MM TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE DISTAL RCA WHERE THERE WAS IN-STENT STENOSIS FROM A PREVIOUS STENT. THE TAXUS LIBERTE STENT WAS DEPLOYED AT 13ATMS AND POST DILATED WITH LOW PRESSURE INFLATIONS TO 4ATMS. ANGIOGRAPHY REVEALED TIMI 3 FLOW. NEXT, A TAXUS 2.5X12MM SDS WAS ADVANCED TO THE PROXIMAL RCA AND THE STENT WAS DEPLOYED TO 14ATMS AND WAS POST DILATED TO 15ATMS. ADDITIONAL LOW PRESSURE INFLATIONS TO 5 ATMS WERE PERFORMED. ANGIOGRAM REVEALED TIMI 3 FLOW WITH 0% STENOSIS. THE PATIENT WAS PLACED ON ECOTRIN AND PLAVIX AND WILL RESUME TAKING LIPITOR. FOURTEEN DAYS LATER, THE PATIENT HAD A ST ELEVATED INFERIOR WALL MYOCARDIAL INFARCTION (STEMI) AND WAS ADMINISTERED TNKASE. IT WAS NOTED THAT THE PATIENT WAS NONCOMPLIANT AND STOPPED TAKING PLAVIX. TWO DAYS AFTER THE MI, A CARDIAC CATHETERIZATION REVEALED THAT THE DISTAL RCA HAD 95% LUMINAL NARROWING AND THE ARTERY WAS SIGNIFICANTLY SMALL EXCEPT WHERE IT HAD BEEN PREVIOUSLY STENTED. INTRACORONARY INJECTION OF 100MCG OF NITRO WAS GIVEN AND THE 95% NARROWING IN THE DISTAL RCA RESOLVED AND THE SIZE OF THE ARTERY IMPROVED. THE AREA OF THE STENTS DID NOT HAVE SIGNIFICANT STENOSIS OR THROMBUS HOWEVER PER THE PHYSICIAN THE MI WAS DUE TO A COMBINATION OF THE SPASM AND POTENTIAL ACUTE IN-STENT THROMBOSIS.

    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 H7493893616220

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R PROWATER GUIDEWIRE| TAXUS 2.5X12| JR 4.0 GUIDE CATHETER