BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1801979 · Received August 16, 2010

    Report

    Report Number
    2134265-2010-03613
    Event Type
    Death
    Date Received
    August 16, 2010
    Date of Event
    February 14, 2010
    Report Date
    July 21, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT.(B)(4).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

    (B)(4). SAME CASE AS MFR ID#: 2134265-2010-03612. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, PATIENT DEATH OCCURRED. TWO TARGET LESIONS WERE TREATED AT THE INDEX PROCEDURE. THE FIRST LESION TREATED, LOCATED IN THE RIGHT POSTERIOR DESCENDING CORONARY ARTERY, WAS 8MM LONG AND 70% STENOSED WITH A REFERENCE VESSEL DIAMETER OF 2.4MM. IT WAS TREATED WITH PLACEMENT OF AN UNKNOWN SIZE TAXUS EXPRESS2 STENT AND POST DILATION. ANGIOGRAPHY INDICATED CLINICAL SUCCESS. THE SECOND WAS A 90% STENOSED AND 24MM LONG LESION LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING CORONARY ARTERY WITH A REFERENCE VESSEL DIAMETER OF 2.2MM. THE FIRST ATTEMPT TO IMPLANT A STUDY STENT IN THIS TARGET VESSEL FAILED AS THE DEVICE COULD NOT CROSS THE LESION. THE LESION WAS THEN PREDILATED, AND A 2.25X32MM TAXUS LIBERTE ATOM MONORAIL WAS DEPLOYED FOLLOWED BY POST DILATION RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED 1 DAY LATER ON ASPIRIN AND CLOPIDOGREL. AT 1683 DAYS POST INDEX PROCEDURE, THE PATIENT COLLAPSED IN HIS HOME. EMERGENCY MEDICAL SERVICES TRANSPORTED THE PATIENT TO THE HOSPITAL. HE WAS REPORTED TO BE ASYSTOLIC AND SUBSEQUENTLY INTUBATED AND GIVEN THREE ROUNDS OF ADVANCED CARDIAC LIFE SUPPORT MEDICATION VIA AN INTEROSSEOUS LINE IN THE LEFT LEG WITH NO IMPROVEMENT NOTED. AT THE HOSPITAL, HE WAS PLACED ON CARDIAC MONITORS AND CONTINUED TO BE ASYSTOLIC. CHEST COMPRESSIONS WERE PERFORMED. THERE WAS A RETURN OF ELECTRICAL ACTIVITY WITH FAINT PULSES. HE WAS THEN SHOCKED ONCE AND HIS RHYTHM RETURNED TO ASYSTOLE. CARDIAC ULTRASOUND REVEALED THERE WAS NO CARDIAC ACTIVITY AND THE PATIENT WAS PRONOUNCED DEAD. PER THE DEATH CERTIFICATE, THE CAUSE OF DEATH IS LISTED AS CORONARY ARTERY DISEASE. 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 - MAPLE GROVE UNK432

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death NC RANGER BALLOON| 2.25X32MM TAXUS LIBERTE ATOM STENT| MAVERICK2 BALLOON