BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT

    MDR report key: 774909 · Received October 27, 2006

    Report

    Report Number
    6000089-2006-02324
    Event Type
    Injury
    Date Received
    October 27, 2006
    Date of Event
    September 7, 2006
    Report Date
    October 6, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. SHOULD FURTHER RELEVANT INFORMATION BECOME AVAILABLE; A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    CLINICAL STUDY. IT WAS REPORTED THAT 113 DAYS AFTER A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE THE PATIENT REQUIRED A TARGET VESSEL REINTERVENTION (TVR). THE INDEX PROCEDURE TREATED A 3.1X16MM, 80% STENOSED, MILDLY CALCIFIED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (PROX LAD) WITH PLACEMENT OF A TAXUS EXPRESS2 3.0X20MM DRUG ELUTING STENT, REDUCING STENOSIS TO 0%. THE PROCEDURE ALSO TREATED A 2.8X15MM, 70% STENOSED, MILDLY TORTUOUS LESION IN THE 1ST LEFT POSTEROLATERAL BRANCH (1ST LPL) WITH PLACEMENT OF A TAXUS EXPRESS2 2.75X20MM DRUG ELUTING STENT. POST-DILATED LESION HAD 0% STENOSIS. THERE WERE NO REPORTED COMPLICATIONS. THE PATIENT WAS DISCHARGED 2 DAYS LATER ON ASPIRIN AND PLAVIX. AT 113 DAYS AFTER THE INDEX PROCEDURE THE PATIENT REQUIRED A TVR FOR IN-STENT FOCAL RESTENOSIS IN THE 1ST LPL. TWO TAXUS EXPRESS2 DRUG ELUTING STENTS WERE PLACED IN THE 1ST LPL. THE PATIENT WAS DISCHARGED THE NEXT DAY. IN THE OPINION OF THE PHYSICIAN, THE RELATIONSHIP OF THE TVR TO THE TAXUS STENT IS PROBABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT DRUG ELUTING STENT NIQ BOSTON SCIENTIFIC 2.75X20MM 7297240

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R