BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1242995 · Received November 21, 2008

    Report

    Report Number
    2134265-2008-04450
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    August 20, 2008
    Report Date
    October 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 THE REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    CLINICAL STUDY. SAME CASE AS 2134265-2008-04449, 2134265-2008-04451. THE LESION BEING TREATED WAS A 3.5MM, 90% STENOSED, 32.0MM LONG PORTION OF THE 2ND OBTUSE MARGINAL (2ND OB MARG). THE PHYSICIAN PRE-DILATED THE LESION WITH A 2.5X15MM BALLOON (18 ATMS), AND IMPLANTED A TAXUS 2.75X16MM STUDY STENT (20ATM) AND A TAXUS 3.5X32MM STUDY STENT (20ATM) IN THE TARGET LESION. WHEN IMPLANTING THE TAXUS 2.75X16MM STENT, A DISSECTION AT THE DISTAL SIDE OF 2ND OBTUSE MARGINAL BRANCH OCCURRED. THE PHYSICIAN THEN PLACED A TAXUS 2.5X12MM STENT (20ATM) FOR THE TREATMENT. IVUS WAS PERFORMED AND CONFIRMED THE STENTS WERE IMPLANTED PROPERLY. STENOSIS IN THE LESION BECAME 0%. TIMI FLOW: 3. THE PATIENT WAS DISCHARGE 12 DAYS LATER. IN 2008, THE PATIENT EXPERIENCED A "FEVER OF UNKNOWN ORIGIN", WORSENING OF MYELODYSPLASTIC SYNDROMES (TREATED WITH BLOOD TRANSFUSION), WORSENING OF DIABETES AND CONFIRMATION OF AN ADENOMATOUS GOITER. PER THE PHYSICIAN, THESE EVENTS ARE "NOT RELATED" TO THE TAXUS STENTS". AT 169 DAYS AFTER THE INDEX PROCEDURE, CAG WAS PERFORMED FOR FOLLOW-UP AND RE-STENOSIS IN LCX PROXIMAL, 1ST AND 2ND OBTUSE MARGINAL BRANCH AND LCX DISTAL WAS FOUND. SIX DAYS LATER, RE-INTERVENTION WAS PERFORMED IN THE LCX DISTAL. THE LESION WAS DILATED WITH UNKNOWN BALLOON. STENOSIS IN THE LESION BECAME 0%. ALSO, LATE STENT THROMBOSIS IN LCX PROXIMAL, 1ST AND 2ND OBTUSE MARGINAL BRANCH AND LCX DISTAL WAS CONFIRMED. IN THE OPINION OF THE PHYSICIAN, THE RELATIONSHIP TO THE TAXUS STENT IS POSSIBLE. THE PATIENT WAS DISCHARGED 12 DAYS LATER ON CONTINUED PANALDINE AND ASPIRIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC 3.50X32MM

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R