BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL - ELUTING CORONARY ST

    MDR report key: 743837 · Received August 1, 2006

    Report

    Report Number
    6000089-2006-01552
    Event Type
    Death
    Date Received
    August 1, 2006
    Date of Event
    July 2, 2006
    Report Date
    July 3, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A UNIT HAS NOT BEEN RETURNED FOR REVIEW, THEREFORE, A TECHNICAL ANALYSIS CANNOT BE CARRIED OUT. IT IS NOT CLEAR FROM THE COMPLAINT DESCRIPTION HOW THIS DEVICE MAY HAVE INFLUENCED THE INCIDENT. WITHOUT A RETURNED UNIT, IT IS NOT POSSIBLE TO CONFIRM HOW THE DEVICE MAY HAVE CONTRIBUTED TO THE COMPLAINT INCIDENT. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS PARTICULAR BATCH NAMELY TOP ASSEMBLY BATCH # 8213781 FOUND THAT THE DEVICE MET IS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS, AT THE TIME OF RELEASE TO DISTRIBUTION. NO FURTHER CORRECTIVE ACTION IS PLANNED AT THIS TIME. ALL RELEVANT PERSONNEL HAVE BEEN NOTIFIED OF THIS COMPLAINT. WE WILL, HOWEVER, CONTIUE TO MONITOR AND TREND THIS TYPE OF COMPLAINT IN ORDER TO ENSURE THAT THERE IS NO COMPROMISE WITH PRODUCT QUALITY. THIS PARTICULAR BATCH #8213781 HAS ONE OTHER ASSOCCIATED COMPLAINT.

    Description of Event or Problem · 1

    CLINICAL TRIAL. SAME CASE AS 6000093-2006-01387, 01388 6000089-2006-01554-01552 SAME PATIENT AS MFR # 6000093-2006-01310. IT WAS REPORTED THAT 13 DAYS POST INDEX PROCEDURE, THE PATIENT EXPIRED. THE INDEX PROCEDURE TREATED 4 TARGET VESSELS. TARGET LESION 1 WAS IN THE PROXIMAL CIRCUMFLEX AND RECEIVED A TAXUS EXPRESS2 2.5 X 12MM STENT, ALONG WITH A TAXUS EXPRESS2 2.5 X 20 MM STENT. THERE WAS OVERLAP OF THE 2 STENTS IN THIS LESION. TARGET LESION 2 WAS IN THE MID LAD AND RECEIVED A TAXUS EXPRESS2 2.75 X 32 MM STENT. LESION 3 WAS IN THE LEFT MAIN AND RECEIVED A TAXUS EXPRESS2 3.5 X 16MM STENT. LESION 4 WAS IN THE MID AND DISTAL LAD AND RECEIVED A TAXUS EXPRESS2 2.5 X 12 MM STENT. ALL LESIONS WERE DIRECT STENTED. AFTER MULTIPLE ATTEMPTS TO CROSS A LESION IN THE LAD WITH A TAXUS EXPRESS2 2.25 X 16 MM STENT, THE STENT DELIVERY SYSTEM SHAFT WAS BROKEN. THE ENTIRE SYSTEM WAS REMOVED EASILY, AND 3 ARTHOS PICO STENTS WERE PLACED INSTEAD. THE PATIENT ALSO RECEIVED HEPARIN, NITRATES, AND AN UNSPECIFIED CATECHOLAMINE DURING THE PROCEDURE. PERI PROCEDURE, THE PATIENT EXPERIENCED A PERFORATED MID LAD WHICH RESULTED IN CARDIAC TAMPONADE AND SUBSEQUENT CARDIOGENIC SHOCK. THE EVENT WAS NOTED AS RESOLVED THE FOLLOWING DAY. A UNIT HAS NOT BEEN RETURNED FOR REVIEW, THEREFORE, A TECHNICAL ANALYSIS CANNOT BE CARRIED OUT. IT IS NOT CLEAR FROM THE COMPLAINT DESCRIPTION HOW THIS DEVICE MAY HAVE INFLUENCED THE INCIDENT. WITHOUT A RETURNED UNIT IT IS NOT POSSIBLE TO CONFIRM HOW THE DEVICE MAY HAVE CONTRIBUTED TO THE COMPLAINT INCIDENT. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS PARTICULAR BATCH NAMELY TOP ASSEMBLY BATCH #8213781 FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS, AT THE TIME OF RELEASE TO DISTRIBUTION. NO FURTHER CORRECTIVE ACTION IS PLANNED AT THIS TIME. ALL RELEVANT PERSONNEL HAVE BEEN NOTIFIED OF THIS COMPLAINT. WE WILL, HOWEVER, CONTINUE TO MONITOR AND TREND THIS TYPE OF COMPLAINT IN ORDER TO ENSURE THAT THERE IS NO COMPROMISE WITH PRODUCT QUALITY. THIS PARTICULAR BATCH #8213781 HAS ONE OTHER ASSOCIATED COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL - ELUTING CORONARY ST DRUG COATED STENT NIQ BOSTON SCIENTIFIC CORP. 2.5X 12 MM 8213781

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death