BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1850333 · Received October 1, 2010

    Report

    Report Number
    2134265-2010-04404
    Event Type
    Death
    Date Received
    October 1, 2010
    Date of Event
    April 9, 2010
    Report Date
    September 9, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTER: 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

    SAME CASE AS MFR#: 2134265-2010-04405, 2134265-2010-04406. (B)(4). IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PATIENT EXPIRED. IN (B)(6) 2005, THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY WAS TREATED WITH A 2.75X28MM TAXUS EXPRESS2 STENT. RESIDUAL STENOSIS WAS LESS THAN OR EQUAL TO 30%. THE OBTUSE MARGINAL WAS ASSESSED AS A TYPE E BIFURCATION LESION AND WAS TREATED VIA PROVISIONAL T-STENTING. THE SIDE BRANCH WAS TREATED WITH A 2.25X24MM TAXUS EXPRESS2 STENT. RESIDUAL STENOSIS IN BOTH THE MAIN VESSEL AND SIDE BRANCH WAS LESS THAN OR EQUAL TO 30%. A STAGED PROCEDURE WAS PLANNED DUE TO THE PATIENT'S RENAL INSUFFICIENCY AND AGE. THE PATIENT WAS DISCHARGED 1 DAY LATER ON ASA AND CLOPIDOGREL AND OTHERS. AT 3 MONTHS LATER, THE PATIENT UNDERWENT THE STAGED PROCEDURE. THE DISTAL RIGHT CORONARY ARTERY WAS ASSESSED AS A TYPE A BIFURCATION LESION AND WAS TREATED VIA PROVISIONAL T-STENTING. THE MAIN VESSEL WAS TREATED WITH A 2.75X16MM TAXUS LIBERTE STENT. RESIDUAL STENOSIS IN BOTH THE MAIN AND SIDE BRANCH WAS LESS THAN OR EQUAL TO 30%. IN APRIL 2010 THE PATIENT EXPIRED. CAUSE OF DEATH IS UNKNOWN, HOWEVER, THE SITE REPORTED THE TERM "CARDIAC". ADDITIONAL INFORMATION HAS BEE REQUESTED AND IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT'S DEATH WAS DUE TO CARDIAC ARREST.

    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 UNK432

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death 2.25X24MM TAXUS EXPRESS2 STENT| 2.75X16MM TAXUS LIBERTE STENT