BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1011670 · Received March 10, 2008

    Report

    Report Number
    2134265-2008-00714
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    December 5, 2007
    Report Date
    February 14, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL, 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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    TAXUS EXPRESS2 POST MARKET SURVEILLANCE STUDY, IT WAS REPORTED THAT DURING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE STENT WAS DAMAGED. TWO TARGET LESIONS WERE IDENTIFIED. LESION ONE WAS LOCATED IN THE DISTAL RCA (RIGHT CORONARY ARTERY). LESION ONE WAS DE NOVO, 90% STENOSED AND MEASURED 3.5X12MM. LESION TWO WAS LOCATED IN THE PROXIMAL RCA. LESION TWO WAS A DE NOVO, 75% STENOSED AND MEASURED 3.5X25MM. THE DISTAL RCA WAS PRE-DILATED USING A 3.0X15MM BALLOON AT 8ATM AND A TAXUS STENT WAS DEPLOYED IN THE LESION AT 14ATM. NEXT, THE PROXIMAL RCA WAS PRE-DILATED USING A 3.0X15MM BALLOON AT 8ATM. THE PHYSICIAN ATTEMPTED TO IMPLANT THIS 3.5X32MM TAXUS EXPRESS2 DRUG ELUTING STENT, BUT THE DELIVERY SYSTEM WAS NOT ABLE TO CROSS TO THE LESION. WHEN HE ATTEMPTED TO REMOVE THE DELIVERY SYSTEM, THE STENT CAUGHT ON THE GUIDE CATHETER AND THE PROXIMAL STRUTS LIFTED UP. ANOTHER 3.5X32MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS THEN DEPLOYED IN THE LESION AT 12ATM. THE PHYSICIAN CONFIRMED VIA IVUS (INTRAVASCULAR ULTRASOUND) THAT RESIDUAL STENOSIS WAS 0% AND TIMI GRADE WAS 3. THE STENTS WERE WELL POSITIONED AND WELL APPOSED. THERE WERE NO COMPLICATIONS AND INJURIES TO THE PATIENT.

    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 CORPORATION 3.5X32MM 9477989

    Patients

    Seq Age Sex Outcome Treatment
    1