BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1032886 · Received April 23, 2008

    Report

    Report Number
    2134265-2008-01171
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    March 25, 2008
    Report Date
    April 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING A DETAILED DEVICE ANALYSIS BY THE COMPLAINT INVESTIGATION SITE (CIS), IT WAS NOTED THAT THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT. A VISUAL AND MICROSCOPIC EXAMINATION FOUND DAMAGE TO THE DISTAL EDGE OF THE STENT. THE FIRST DISTAL ROW STRUTS WERE SLIGHTLY FLARED. THE DAMAGED SECTION WAS MEASURED WITH A SNAP GAUGE, TO HAVE AN APPROXIMATE DIAMETER OF 1.33MM, WHICH WAS MEASURED TO BE 0.10MM GREATER THAN THE NORMAL STENT DIAMETER. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE DELIVERY SYSTEM ENCOUNTERING SOME FORM OF RESTRICTION. THE HYPOTUBE HAD KINKED TWICE, APPROXIMATELY 4.4CM AND 16.4CM DISTAL FROM THE CATHETERS STRAIN RELIEF. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. A RECOMMENDED SIZED GUIDEWIRE (0.014 INCH) WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTIONS NOTED. THE BALLOON AND TIP SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO ANY POSITIVE PRESSURE. A LABELING REVIEW IDENTIFIED THAT THE DEVICE WAS USED PER THE TAXUS EXPRESS2 DIRECTIONS FOR USE (DFU). HOWEVER, THE COMPLAINT STATES THAT THE CONDITION OF THE TARGET LESION WAS REPORTED AS HEAVILY CALCIFIED AND SEVERELY TORTUOUS WITH ANGULATIONS, WHICH COULD HAVE BEEN POTENTIAL CONTRIBUTING FACTORS TO THE COMPLAINT INCIDENT. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOUND NO ANOMALIES. THE MOST PROBABLE ROOT CAUSE WILL BE NOTED AS OPERATIONAL CONTEXT. A CORRECTIVE AND PREVENTIVE ACTION HAS BEEN INITIATED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    BASED ON ANALYSIS COMPLETED ON 04/22/2008, THIS IS NOW A REPORTABLE COMPLAINT. THE PHYSICIAN ATTEMPTED TO TREAT A DE NOVO LESION IN THE MID CIRCUMFLEX (CX). THE LESION WAS 2.75 MM WIDE, 10 MM LONG, AND 95% STENOSED. THERE WAS A 90 DEGREE BEND IN THE LESION. THE LESION HAD HEAVY CALCIFICATION AND SEVERE TORTUOSITY AS WELL. THE PHYSICIAN PREDILATED THE LESION WITH A 2.5/20 MAVERICK2 BALLOON. THE PHYSICIAN THEN ATTEMPTED TO PLACE A 2.75 X 16 MM TAXUS EXPRESS2 STENT, BUT THE STENT WOULD NOT CROSS THE LESION. THE PATIENT RECEIVED HEPARIN AND NITROGLYCERIN DURING THE PROCEDURE. THE PHYSICIAN ABORTED THE PROCEDURE, AND THE EVENT RESOLVED. THERE WERE NO PATIENT COMPLICATIONS. PATIENT CONDITION IS REPORTED AS STABLE.

    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 2.75 X 16 MM 9599744

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR