BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1416322 · Received July 17, 2009

    Report

    Report Number
    2134265-2009-03402
    Event Type
    Injury
    Date Received
    July 17, 2009
    Date of Event
    December 18, 2008
    Report Date
    June 19, 2009
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE UNIT HAS NOT BEEN RETURNED, A TECHNICAL ANALYSIS WAS UNABLE TO BE PERFORMED. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS BATCH FOUND THAT THE DEVICES MET THEIR MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATION AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU.

    Description of Event or Problem · 1

    CLINICAL STUDY. SAME CASE AS 2134265-2009-XXXX. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING PROCEDURE THE PATIENT EXPERIENCED RESTENOSIS AND REQUIRED A TARGET VESSEL REINTERVENTION (TVR). LESION 1 WAS A 3.50MM, 18.0MM LONG, 90% STENOSED PORTION OF THE PROXIMAL LEFT ANTERIOR DESCENDING (PROX LAD) ARTERY. THE PHYSICIAN TREATED THE LESION WITH PREDILATATION USING A 3.0X8MM BALLOON, TYPE UNKNOWN. THE PHYSICIAN THEN PLACED A 3.50X12MM TAXUS EXPRESS2 STUDY STENT IN THE TARGET LESION. IVUS WAS USED TO CONFIRM PLACEMENT AND THE LESION WAS NOT POST DILATED. LESION 2 WAS A 2.50MM, 90% STENOSED, 20.0MM LONG PORTION OF THE DISTAL LEFT ANTERIOR DESCENDING (DIST LAD) ARTERY. THE PHYSICIAN TREATED THE LESION WITH DIRECT PLACEMENT OF A 2.50X20MM TAXUS EXPRESS2 STUDY STENT. POST DILATATION WITH A 3.0X8MM BALLOON AND IVUS WAS PERFORMED TO CONFIRM PLACEMENT. THE PATIENT WAS DISCHARGED 2 DAYS LATER, 203 DAYS AFTER THE INDEX PROCEDURE THE PATIENT WAS HOSPITALIZED AND A TVR PERFORMED. THE PHYSICIAN PLACED A TAXUS STENT OF UNKNOWN TYPE AND SIZE IN THE PROX LAD. THEN HE SUCCESSFULLY PLACED A NON BSC STENT IN THE DIST LAD. THE PATIENT WAS DISCHARGED ON PLAVIX AND ASPIRIN. NO FURTHER PROBLEMS WERE NOTED.

    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 3.50X12MM

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R