BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1658230 · Received April 13, 2010

    Report

    Report Number
    2134265-2010-01968
    Event Type
    Death
    Date Received
    April 13, 2010
    Date of Event
    June 24, 2009
    Report Date
    March 17, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4)

    Additional Manufacturer Narrative · 1

    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. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B) (4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE CAUSE OF DEATH WAS ARTERIOSCLEROTIC CARDIOVASCULAR DISEASE. IT IS THE OPINION OF THE PHYSICIAN THAT THIS EVENT IS UNRELATED TO THE TAXUS EXPRESS2 STENT. CORRECTION: IT WAS PREVIOUSLY REPORTED THAT ONE 3.5X32MM TAXUS EXPRESS2 STENT WAS IMPLANTED IN THE LEFT MAIN ARTERY, ONE 3.5X32MM TAXUS EXPRESS2 STENT WAS IMPLANTED IN THE PROXIMAL CIRCUMFLEX, AND ONE 2.5X8MM TAXUS EXPRESS2 STENT IMPLANTED IN THE DISTAL CIRCUMFLEX ARTERY. HOWEVER, THE SITE HAS CORRECTED THE EVENT SUCH THAT ONE TAXUS EXPRESS2 3.5X32MM STENT WAS IMPLANTED IN THE LEFT MAIN EXTENDING INTO THE PROXIMAL CIRCUMFLEX ARTERY, AND ONE TAXUS EXPRESS2 2.5X8MM STENT WAS IMPLANTED IN THE DISTAL CIRCUMFLEX ARTERY. SO THE PATIENT HAD TWO STENTS IMPLANTED AT THE INDEX PROCEDURE INSTEAD OF THREE.

    Description of Event or Problem · 1

    (B) (4). SAME CASE AS MFR REPORT #: 2134265-2010-01967, 2134265-2010-01969. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PATIENT EXPIRED. THREE TARGET LESIONS WERE TREATED AT THE INDEX PROCEDURE. THE FIRST WAS LOCATED IN THE LEFT MAIN, AND WAS TREATED WITH PLACEMENT OF A 3.5X32MM TAXUS EXPRESS2 STENT RESULTING IN LESS THAN OR EQUAL TO 30% RESIDUAL STENOSIS. ANOTHER LESION LOCATED IN THE PROXIMAL CIRCUMFLEX ARTERY WAS TREATED WITH PLACEMENT OF A 3.5X32MM TAXUS EXPRESS2 STENT RESULTING IN LESS THAN OR EQUAL TO 30% RESIDUAL STENOSIS. A 3RD LESION LOCATED IN THE DISTAL CIRCUMFLEX ARTERY WAS TREATED WITH PLACEMENT OF A 2.5X8MM TAXUS EXPRESS2 STENT RESULTING IN LESS THAN OR EQUAL TO 30% RESIDUAL STENOSIS. TWO OTHER LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY AND PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY WERE NOT TREATED DUE TO TOTAL OCCLUSION. THE PATIENT WAS DISCHARGED 1 DAY LATER ON ASPIRIN AND CLOPIDOGREL. AT 859 DAYS POST INDEX PROCEDURE, IT WAS REPORTED THAT THE PATIENT DIED AT HOME. THE CAUSE OF DEATH WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    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 H7493897032350 8862657

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death 2.5X8 MM TAXUS EXPRESS2 STENT| 3.5X32 MM TAXUS EXPRESS2 STENT