BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1761926 · Received July 19, 2010

    Report

    Report Number
    2134265-2010-00452
    Event Type
    Injury
    Date Received
    July 19, 2010
    Date of Event
    December 16, 2008
    Report Date
    February 19, 2009
    Manufacturer
    BOSTON SCIENTIFIC IRELAND LTD.
    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

    THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNKNOWN. THEREFORE A REVIEW OF THE MANUFACTURING DOCUMENTATION COULD NOT BE PERFORMED.THE MOST PROBABLE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATION AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED IN THE DIRECTION FOR USE (DFU). (B) (4): DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    (B) (4). IT WAS REPORTED THAT POST A CORONARY ARTERY DRUG-ELUTING STENTING TREATMENT PROCEDURE, RESTENOSIS OCCURRED. THE INDEX PROCEDURE TREATED THE 90% STENOSED, 3.0X12.0MM TARGET LESION LOCATED IN THE RIGHT POSTERIOR DESCENDING ARTERY (R-PDA). TREATMENT CONSISTED OF PRE-DILATION AND PLACEMENT OF A 3.00×12MM TAXUS EXPRESS2 STENT WITH 0% RESIDUAL STENOSIS. A 100% STENOSED, 3.00X14.8MM NON-TARGET LESION LOCATED IN THE RIGHT POSTEROATRIOVENTRICULAR (PAV) WAS TREATED WITH PLACEMENT A 3.00X16MM TAXUS EXPRESS2 STENT. RESIDUAL STENOSIS WAS 0%. IN (B) (6) 2008, THE PATIENT HAD A FOLLOW UP VISIT AND THERE WAS 100% RESTENOSIS AT THE STENTED SEGMENT WITH THE TAXUS EXPRESS 2 STENT IN THE RIGHT PAV. THE PHYSICIAN IN CHARGE OF THE INVESTIGATION REPORTED THAT RCA3 INSTEAD OF LCX HAS COLLATERAL CIRCULATION AND THE CONDITION WOULD NOT BE TREATED SINCE THERE WERE NO SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC IRELAND LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other