BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1023383 · Received April 2, 2008

    Report

    Report Number
    2134265-2008-00935
    Event Type
    Injury
    Date Received
    April 2, 2008
    Date of Event
    November 24, 2007
    Report Date
    March 10, 2008
    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, THE COMPLAINT INVESTIGATION SITE (CIS) COULD NOT PERFORM A TECHNICAL ANALYSIS. ALL TAXUS EXPRESS2 UNITS SHIPPED FOR THE BATCH CONFORMED TO THE PREVENTATIVE MEASURES/CURRENT CONTROLS AS PER PRODUCT SPECIFICATION FOR THE TAXUS EXPRESS2 STENT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND NO ANOMALIES OR DEVIATIONS DURING THE MFR OF THIS BATCH. A CORRECTIVE AND PREVENTATIVE ACTION HAS BEEN OPENED TO ADDRESS THE AS REPORTED CLINICAL EFFECT FOR PT COMPLICATIONS. THE MOST PROBABLE ROOT CAUSE OF THIS DEFECT WILL BE DOCUMENTED AS ANTICIPATED PROCEDURAL COMPLICATION DUE TO THE LIKELIHOOD THAT THE PT ANATOMY OR OTHER PROCEDURAL FACTORS CONTRIBUTED TO THE REPORTED DIFFICULTIES AND DUE TO THE LACK OF INFO IMPLICATING A ROOT CAUSE RELATED TO THE DEVICE.

    Description of Event or Problem · 1

    CLINICAL STUDY. IT WAS REPORTED THAT 2 DAYS AFTER A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PT EXPERIENCED A PSEUDOANEURYSM AT THE PUNCTURE SITE. THE LESION BEING TREATED WAS A 3.25 MM, 28 MM LONG, 90% STENOSED, DE NOVO PORTION OF THE MID LEFT ANTERIOR DESCENDING (MID LAD) ARTERY. THE LESION WAS PRE-DILATED WITH A 2.5 X 14MM BALLOON AT MAXIMUM 8 ATM. THE PHYSICIAN THEN PLACED A TAXUS EXPRESS2 3.0 X 32MM STUDY STENT. THE STENT WAS POST-DILATED WITH A 3.5 X 10MM BALLOON. POST-IVUS WAS PERFORMED CONFIRMING 0% STENOSIS. THE STENT PLACEMENT WAS WELL POSITIONED AND WELL APPOSED. TWO DAYS AFTER THE INDEX PROCEDURE, AROUND THE PUNCTURE SITE (FEMORAL ARTERY) SWELLED UP. THE PT COMPLAINED OF MILD TENDERNESS. ECHO EXAMINATION WAS PERFORMED. THE PHYSICIAN CONFIRMED PSEUDOANEURYSM OF THE DORSAL SIDE OF THE PUNCTURE SITE. THE PHYSICIAN ATTEMPTED TO COMPRESS UNDER ECHO, HOWEVER THE ATTEMPT WAS INEFFECTIVE. ECHO EXAMINATION WAS PERFORMED AGAIN. THE PHYSICIAN CONFIRMED THE PSEUDOANEURYSM DID NOT EXPAND. THE PT WILL BE TREATED AT THE HOSPITAL AS AN OUTPATIENT. ACCORDING TO THE PHYSICIAN THE IMPLANTATION OF THE TAXUS EXPRESS2 STENT DID NOT RELATE TO THIS EVENT. THE PT WAS DISCHARGED 3 DAYS LATER. PT STATUS IS STABLE.

    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 3.00X32MM 9693406

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R