BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2005430 · Received March 2, 2011

    Report

    Report Number
    2134265-2011-00753
    Event Type
    Death
    Date Received
    March 2, 2011
    Date of Event
    October 5, 2010
    Report Date
    February 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2011-00754. (B)(6). IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPIRED. THE INDEX PROCEDURE TREATED TWO TARGET LESIONS. TARGET LESION ONE WAS IN THE 2.5MM, 90% STENOSED RIGHT POSTERIOR ATRIOVENTRICULAR (R-PAV) ARTERY. TREATMENT CONSISTED OF DIRECT STENTING USING A 2.5X8MM TAXUS EXPRESS2 STENT DEPLOYED AT 10ATM RESULTING IN 0% STENOSIS AND GOOD IMPLANTATION AFTER IVUS (INTRAVASCULAR ULTRASOUND). TARGET LESION TWO WAS 2.0X10MM WITH 99% STENOSIS OF THE RIGHT POSTERIOR DESCENDING ARTERY (R-PDA). TREATMENT CONSISTED OF PREDILATION WITH A 2.0X10MM BALLOON AT 6ATM AND PLACEMENT OF A 2.5X16MM TAXUS EXPRESS2 STENT DEPLOYED AT 16ATM RESULTING IN 0% RESIDUAL STENOSIS AND GOOD IMPLANTATION AFTER IVUS. BOTH LOCATIONS HAD TIMI 3 FLOW POST STENTING. IN (B)(6) 2010, THE PATIENT'S FAMILY WAS UNABLE TO WAKE THE PATIENT. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL BY AMBULANCE. THE PATIENT WAS IN CARDIOPULMONARY ARREST UPON ARRIVAL BUT WAS UNABLE TO BE REVIVED. NO AUTOPSY WAS PERFORMED.

    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 - GALWAY H7493897008250 9634827

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death