BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1021255 · Received March 28, 2008

    Report

    Report Number
    2134265-2008-00913
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    November 28, 2007
    Report Date
    March 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IN THE PATIENT AND THE DELIVERY DEVICE HAS BEEN DISPOSED; THEREFORE, NO DIRECT PRODUCT ANALYSIS WILL BE AVAILABLE. UPON REVIEW OF AVAILABLE INFORMATION RELATED TO THIS EVENT, THERE IS NO EVIDENCE TO INDICATE THE STENT MALFUNCTIONED OR FAILED TO PERFORM TO SPECIFICATION. THE ROOT CAUSE WILL BE DOCUMENTED AS ANTICIPATED PROCEDURAL COMPLICATIONS BECAUSE ALLERGIC REACTION TO ANTICOAGULANT AND/OR ANTITHROMBOTIC THERAPY, CONTRAST MEDIUM OR STENT MATERIAL HAS BEEN IDENTIFIED AS A POTENTIAL ADVERSE EVENT. THE MANUFACTURING RECORDS FOR THE TOP ASSEMBLY BATCH WERE REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THE RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS PRIOR TO SHIPMENT. AS NO DEVICE WAS RECEIVED FOR ANALYSIS, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE DIFFICULTIES EXPERIENCED WITH THIS COMPLAINT INCIDENT.

    Description of Event or Problem · 1

    POST MARKET SAFETY SURVEILLANCE. IT WAS REPORTED THAT 20 DAYS AFTER A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED AN ALLERGIC REACTION. THE LESION BEING TREATED IN THE INDEX PROCEDURE WAS A 2.5MM, 75% STENOSED, 20MM LONG PORTION OF THE MID LEFT ANTERIOR DESCENDING (MID LAD). THE PHYSICIAN TREATED THE LESION WITH PREDILATION WITH A 2.5X30MM BALLOON AND SUCCESSFUL PLACEMENT OF A TAXUS EXPRESS2 2.50X20MM STUDY STENT. THE LESION WAS POSTDILATED WITH A 2.5X20 BALLOON (TYPE UNKNOWN) AT 11 ATM. THEN IT WAS CONFIRMED WITH IVUS, BUT THE STENT WAS NOT DILATED COMPLETELY. THEREFORE, IT WAS DILATED WITH THE STENT DELIVERY SYSTEM. THE PHYSICIAN ALSO PLACED A NON BSC STENT IN THE MID LAD WITHOUT GAP BETWEEN THE IMPLANTED TAXUS STENT. THEY ALSO TREATED THE LEFT MAIN CORONARY ARTERY WITH A NON BSC STENT. AFTER THE PROCEDURE, THE STENOSIS WAS 0%. TWENTY DAYS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED AN ALLERGIC REACTION DETERMINED TO BE FROM PANALDINE. THE PHYSICIAN CHANGED THE PATIENT'S MEDICATION TO PLAVIX AND THE REACTION DISAPPEARED 49 DAYS LATER. IN THE OPINION OF THE PHYSICIAN, THE REACTION WAS POSSIBLY RELATED TO THE TAXUS STENT AND DEFINITELY RELATED TO THE MEDICATION. A FOLLOW UP PROCEDURE WAS DONE AND THERE WAS NO PROBLEM WITH STENT. THE PATIENT WAS DISCHARGED ON PLAVIX AND ASPIRIN.

    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 2.5X20MM 9438976

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other