BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1080364 · Received July 22, 2008

    Report

    Report Number
    2134265-2008-01968
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    June 24, 2008
    Report Date
    June 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS CONFIRMED THE DIFFICULTY STATED IN THE COMPLAINT. THE RETURNED UNIT CAME BACK WITHOUT THE STENT ATTACHED. THE SDS WAS EXAMINED VISUALLY AND TACTICALLY ALONG THE LENGTH AND NO DEFECTS OR ANOMALIES WERE FOUND. THE DISTAL END OF THE SDS WAS ALSO LOOKED AT UNDER MAGNIFICATION. THE BALLOON HAD THE STENT IMPRESSION STILL PRESENT AS WELL AS EVIDENCE OF PILLOWING. THIS INDICATES THAT THE STENT WAS CRIMPED ADEQUATELY DURING MANUFACTURING. THE MANUFACTURING RECORDS HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WILL BE CONSIDERED OPERATIONAL CONTEXT DUE TO THE LIKELIHOOD OF ANATOMICAL AND OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE WHICH CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    SAME CASE AS 2134265-2008-01969. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DISLODGEMENT OCCURRED. THE LESION WAS PRE-DILATED WITH A QUANTUM MAVERICK 3.5X15MM BALLOON. THE PHYSICIAN ATTEMPTED TO PLACE A TAXUS EXPRESS2 3.5X8MM DRUG ELUTING STENT TO THE 90% STENOSED, CALCIFIED, MODERATELY TORTUOUS, PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY, BUT WAS UNABLE TO CROSS THE LESION. THE STENT DELIVERY SYSTEM (SDS) WAS THEN WITHDRAWN AND AN ATTEMPT WAS MADE TO REPLACE THE NON BSC GUIDE CATHETER, BUT WHILE ENGAGING THE GUIDE CATHETER, A DISSECTION OCCURRED AT THE LEFT MAIN TRUNK (LMT). ANGIOGRAPHY THEN REVEALED THAT THE TAXUS STENT HAD DISLODGED AT THE LMT AND THEN EMBOLIZED TO THE LEFT CIRCUMFLEX (LCX) ARTERY, WHERE IT WAS LEFT UNTREATED. FLOW WAS NOT A PROBLEM. THE PHYSICIAN THEN ATTEMPTED TO TREAT THE DISSECTION WITH A LIBERTE BARE METAL STENT, BUT WAS UNABLE TO CROSS AT THE LMT. SEVERAL ATTEMPTS TO CROSS WERE MADE AND THE LIBERTE STENT DISLODGED AROUND THE LMT. RETRIEVAL OF THIS DISLODGED STENT WAS ATTEMPTED, BUT NOT SUCCESSFUL. THE LIBERTE STENT WAS NOT IMPLANTED COMPLETELY AND AN ADD'L PROCEDURE IS SCHEDULED FOR TREATMENT OF THE DISSECTION AND REMOVAL OF THE LIBERTE STENT. THE PT EXPERIENCED ELEVATED BLOOD PRESSURE DURING THIS PROCEDURE, BUT WAS STABLE POST PROCEDURE AND FLOW WAS GOOD. ADD'L INFO REGARDING THE SURGERY IS NOT AVAILABLE AS THE PROCEDURE WAS PERFORMED AT A DIFFERENT FACILITY.

    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 3.5X8MM 11055796

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LAUNCHER GUIDE CATHETERS| AXCESS