BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT

    MDR report key: 757737 · Received August 28, 2006

    Report

    Report Number
    6000089-2006-01832
    Event Type
    Death
    Date Received
    August 28, 2006
    Date of Event
    February 21, 2006
    Report Date
    July 31, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A UNIT HAS NOT BEEN RETURNED FOR REVIEW, THEREFORE, A TECHNICAL ANALYSIS CANNOT BE CARRIED OUT. 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 # 8153614 FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS, AT THE TIME OF RELEASE TO DISTRIBUTION. ALL RELEVANT PERSONNEL HAVE BEEN NOTIFIED OF THIS COMPLAINT. NO FURTHER CORRECTIVE ACTION IS PLANNED AT THIS TIME. WE WILL, HOWEVER, CONTINUE TO MONITOR AND TREND THIS TYPE OF COMPLAINT IN ORDER TO ENSURE THAT THERE IS NO COMPROMISE WITH PRODUCT QUALITY.

    Description of Event or Problem · 1

    CLINICAL TRIAL. SAME CASE AS MFR#6000089-2006-01830, -01831. IT WAS REPORTED THAT 4 DAYS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION (MI) AND A STENT THROMBOSIS (ST). THE PATIENT ALSO EXPERIENCED A TARGET VESSEL REVASCULARIZATION (TVR) 7 DAYS LATER, AND DIED ONE DAY LATER. THE INDEX PROCEDURE TREATED 2 TARGET VESSELS. TARGET LESION 1 WAS A DE NOVO LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE VESSEL WAS 3.5 MM WIDE, 60 MM LONG, AND 90% STENOSED. THE PHYSICIAN PREDILATED THE LESION PRIOR TO PLACING 2 OVERLAPPING STENTS; A 3.0 X 32 MM TAXUS LIBERTE AS WELL AS A 3.5 X 32 MM TAXUS LIBERTE STENT. TARGET LESION 2 WAS A DE NOVO LESION IN THE PROXIMAL CIRCUMFLEX (CX). THE LESION WAS 3 MM WIDE, 12 MM LONG, AND 70% STENOSED. THE PHYSICIAN PREDILATED THE LESION PRIOR TO PLACING A 3.0 X 16 MM TAXUS LIBERTE STENT. RESIDUAL STENOSIS WAS 0% IN BOTH TARGET VESSELS. THE PATIENT WAS DISCHARGED THAT SAME DAY ON ASPIRIN AND PLAVIX. ON DAY 4, THE PATIENT EXPERIENCED A Q-WAVE MI, CONFIRMED BY ECG. TROPONIN CONSISTENT WITH MI. THE PATIENT UNDERWENT CATHETERIZATION AND AN ST WAS ALSO FOUND IN THE MID RCA. THE PATIENT SUBSEQUENTLY UNDERWENT A TVR TO THE MID RCA FOR 99% STENOSIS. AN EXPORT THROMBECTOMY DEVICE WAS USED, AND A DRIVER BARRE METAL STENT WAS IMPLANTED. RESIDUAL STENOSIS WAS 0% POST TREATMENT. THE EVENT WAS CONSIDERED RESOLVED, ACCORDING TO ELECTRONIC STUDY DOCUMENTS. ONE DAY LATER, THE PATIENT EXPIRED. THE SITE REPORTED THE CAUSE OF DEATH AS MYOCARDIAL INFARCTION AND STENT THROMBOSIS. IN THE OPINION OF THE PHYSICIAN, THERE IS A DEFINITE RELATIONSHIP OF MI, ST, TVR AND DEATH TO THE LIBERTE STENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC CORP. 3.0 X 16 MM 8153614

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death