BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PLACLITAXEL ELUTING CORONARY ST

    MDR report key: 770635 · Received October 17, 2006

    Report

    Report Number
    6000089-2006-02261
    Event Type
    Injury
    Date Received
    October 17, 2006
    Date of Event
    September 12, 2006
    Report Date
    September 19, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A UNIT HAS NOT BEEN RETURNED FOR REVIEW; THEREORE, A TECHNICAL ANALYSIS CANNOT BE CARRIED OUT. WITHOUT A RETURNED UNIT, IT IS NOT POSSIBLE TO CONFIRM HOW THE DEVICE MAY HAVE CONTRIBUTED TO THE COMPLAINT INCIDENT. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS PARTICULAR BATCH NAMELY TOP ASSEMBLY BATCH # 8043267 FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS, AT THE TIME OF RELEASE TO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, IN STENT RESTENOSIS OCCURRED. THE PATIENT INITIALLY PRESENTED WITH CHEST PAIN. THE PATIENT'S ANATOMY WAS MILDY TORTUOUS. THE LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE VESSEL WAS 2.50MM IN DIAMETER AND 70% STENOSED. DURING THE INDEX PROCEDURE, THE PHYSICIAN PRE-DILATED THE LESION WITH A BORA 2.50X10MM BALLOON AND SUCCESSFULLY IMPLANTED A TAXUS EXPRESS2 2.50X12MM DRUG ELUTING STENT (DES) IN THE LAD. PRIOR TO THE PROECEDURE, THE PATIENT WAS USING LIPITOR, SIMVASTATIN AND ORMOX. DURING THE PROCEDURE, THE PATIENT RECEIVED HEPARIN AND PLAVIX. AFTER THE PROCEDURE, THE PATIENT WAS TO USE PLAVIX AND ASA FOR 12 MONTHS. APPROXIMATELY 322 DAYS AFTER THE PROCEDURE, THE PATIENT WAS STILL EXPERIENCING CHEST PAIN. ALTHOUGH IT WAS NOT AS SEVERE AS PRIOR TO THE STENT PLACEMENT, IT WAS DECIDED TO PERFORM DIAGNOSTIC ANGIOGRAPY. IN-STENT RESTENOSIS WAS VISUALIZED AND WAS TREATED BY IMPLANTING A TAXUS EXPRESS2 2.50X16MM DES. THE PATIENT WAS TO CONTINUE PLAVIX AND ASA THERAPY INDEFINITELY. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PLACLITAXEL ELUTING CORONARY ST DRUG COATED STENT NIQ BOSTON SCIENTIFIC 2.50X12MM 8043267

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening| R