BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1840460 · Received September 21, 2010

    Report

    Report Number
    2134265-2010-04156
    Event Type
    Injury
    Date Received
    September 21, 2010
    Date of Event
    March 31, 2007
    Report Date
    August 31, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER - AS A DEVICE HAS NOT BEEN RETURNED, A TECHNICAL ANALYSIS CANNOT BE PERFORMED. A REVIEW OF THE MANUFACTURING RECORDS RELATED TO THE BATCH THAT PRODUCED THE COMPLAINT DEVICE WAS NOT POSSIBLE BECAUSE THE BATCH NUMBER IS UNKNOWN. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, LATE STENT THROMBOSIS AND A MYOCARDIAL INFARCTION OCCURRED. THE PATIENT PRESENTED WITH RECURRENT CHEST PAIN. THE LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A TAXUS EXPRESS2 STENT OF UNKNOWN SIZE WAS IMPLANTED IN THE LESION. APPROXIMATELY ONE MONTH LATER, THREE NON BSC STENTS WERE IMPLANTED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THREE WEEKS AFTER IMPLANT, THE PATIENT HAD A MYOCARDIAL INFARCTION AND THROMBOSIS WAS FOUND IN THE NON BSC STENTS. SIX MONTHS AFTER THE PATIENT'S INITIAL MYOCARDIAL INFARCTION, THE PATIENT SUFFERED ANOTHER MYOCARDIAL INFARCTION AND THROMBOSIS WAS FOUND WITHIN THE TAXUS EXPRESS2 STENT IN THE RCA. IT WAS FURTHER REPORTED THAT THE PATIENT REMAINED ON PLAVIX FOR THREE MONTHS POST STENT IMPLANT AND WAS NOT TAKING ANTIPLATELET THERAPY AT THE TIME OF THE THROMBOSIS. SINCE THE THROMBOSIS EVENTS, THE PATIENT HAS BEEN RESTARTED ON PLAVIX. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT REPORTS CONTINUING SYMPTOMS.

    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 UNK432

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention