BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1901295 · Received November 17, 2010

    Report

    Report Number
    2134265-2010-04990
    Event Type
    Injury
    Date Received
    November 17, 2010
    Date of Event
    September 21, 2007
    Report Date
    October 21, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER. THE COMPLAINANT 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 REPORT #: 2134265-2010-04989. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, A THROMBOSIS AND RESTENOSIS OCCURRED AND THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION. IN (B)(6) 2004, A 3.0X16MM TAXUS EXPRESS2 WAS IMPLANTED IN THE MID RIGHT CORONARY ARTERY. IN (B)(6) 2007, THE PATIENT PRESENTED FOR AN ELECTIVE CARDIAC CATHETERIZATION FOR CHEST PAIN, ANGINA AND A POSITIVE STRESS TEST. A GREATER THAN 50% STENOSED DE NOVO LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY PROXIMAL TO THE PREVIOUSLY PLACED STENT. THE LESION WAS PREDILATED WITH A 3.0X15MM NON BSC BALLOON INFLATED TO 10 ATMS FOR 40 SECONDS. A 3.00X16MM TAXUS EXPRESS2 STENT WAS DEPLOYED AT 13 ATMS FOR 60 SECONDS AND ALTHOUGH THE LESION WAS DISCRETE, THE STENT WAS PLACED OVERLAPPING THE PREVIOUSLY PLACED STENT, AS TO NOT LEAVE ANY GAPS BETWEEN STENTS. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS PLACED ON PLAVIX AND ASPIRIN. IN (B)(6) 2010, THE PATIENT HAD SURGERY FOR A GASTROINTESTINAL ISSUE. POST SURGERY, THE PATIENT PRESENTED WITH A MYOCARDIAL INFARCTION WITH ST ELEVATIONS, IN-STENT THROMBOSIS AND IN-STENT RESTENOSIS. THE PATIENT HAD BEEN ON PLAVIX UNTIL THIS YEAR. THE 90% STENOSED GRADE C LESION MEASURING 28MM IN LENGTH WAS LOCATED IN THE MID RIGHT CORONARY ARTERY THAT HAD A TIMI FLOW OF II. THE LESION WAS PREDILATED WITH A 3.0X25MM NON BSC BALLOON. A 3.0X28MM NON BSC STENT WAS DEPLOYED IN THE LESION. STENOSIS POST PROCEDURE WAS REDUCED TO 0% AND TIMI III FLOW WAS RESTORED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS IS LISTED AS FINE.

    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 H7493897016300

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention 190CM BMW GUIDE WIRE