BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL DRUG ELUTING STENT

    MDR report key: 729201 · Received June 22, 2006

    Report

    Report Number
    6000089-2006-01248
    Event Type
    Death
    Date Received
    June 22, 2006
    Date of Event
    March 1, 2005
    Report Date
    May 31, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINTANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    CLINICAL STUDY. SAME CASE AS 6000089-2006-01245, 01246, 01248, 01249. 4431 DAYS AFTER A CORONARY ARTERY DRUG-ELUTING STENTING TREATMENT PROCEDURE THE PT EXPIRED. THE INDEX PROCEDURE TREATED 5 DE NOVO TARGET LESIONS. TARGET LESION 1 (15 MM LONG) WAS IDENTIFIED IN THE 3RD OB. MARG. (CASS SITE 22) WITH A 95% STENOSIS (PER CATH NOTE) (CRF STSTES 80% STENOSIS) AND A 2.5 MM REFERENCE VESSEL DIAMETER. TARGET LESION 1 WAS TREATED WITH PRE-DILATATION AND PALCEMENT OF A 2.5 X 20 MM TAXUS STENT. RESIDUAL STENOSIS WAS 0%. TARGET LESION 2 (10 MM LONG) WAS IDENTIFIED IN THE DIS. CX (CASS SITE 19) WITH 80% STENOSIS AND A 2.7 MM REFERENCE VESSEL DIAMETER. TARGET LEISON 2 WAS TREATED WITH DIRECT STENT PLACEMENT USING A 2.5 X 16 MM TAXUS STENT. RESIDUAL STENOSIS WAS 0%. TARGET LESION 3 (15 MM LONG) WAS IDENTIFIED IN THE PROX CX (CASS SITE 18) WITH 90% STENOSIS AND A 3.0 MM REFERENCE VESSEL DIAMETER. TARGET LESION 3 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.0 X 12 MM TAXUS STENT. RESIDUAL STENOSIS WAS 0%. TARGET LESION 4 (15 MM LONG) WAS IDENTIFIED IN THE 1ST OB MARG (CASS SITE 20) WITH 60% STENOSIS AND A 2.5 MM REFERENCE VESSEL DIAMETER. TARGET LESION 4 WAS TREATED WITH DIRECT STENT PLACEMENT USING A 2.5 A 16 MM TAXUS STENT. RESIDUAL STENOSIS WAS 0%. TARGET LESION 5 (10 MM LONG) WAS IDENTIFIED IN THE PROX LAD (CASS SITE 12) WITH 90% STENOSIS AND A 3.0 MM REFERENCE VESSEL DIAMETER. TAREGT LESION 5 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.0 X 16 MM TAXUS STENT. RESIDUAL STENOSIS WAS 0%. FOLLOWING THE PROCEDURE, THE PT'S CARDIAC ENZYMES MET GUIDELINE CRITERIA FOR AN MI.CARDIAC ENZYMES SHOWED CPK AT 477 AND CPK-MB AT 202. NO ACTION WAS TAKEN. THE PHYSICIAN INDICATED THE MI WAS PROBABLY RELAETD TO THE TAXUS STENT AND THE TARGET VESSEL. THE PT WAS DISCHARGED 2 DAYS LATER ON ASA AND PLAVIX. THE PT EXPIRED 431 DAYS AFTER THE INDEX PROCEDURE. THE PT WAS UNDERGOING A PROCEDURE AND HAD A CARDIAC ARREST. "THERE WAS NO INFO PROVIDED ON THE PROCEDURE THAT THE PT WAS HAVING WHEN CARDIAC ARREST OCCURRED." NO AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL DRUG ELUTING STENT DRUG ELUTING STENT NIQ BOSTON SCIENTIFIC CORP. 3.0X12MM 6080426

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death