BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1850381 · Received October 1, 2010

    Report

    Report Number
    2134265-2010-04406
    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
    P060008
    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 MANUFACTURER: 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#: 2134265-2010-04404, 2134265-2010-04405. (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 (B)(6) 2010, THE PATIENT EXPIRED. CAUSE OF DEATH IS UNKNOWN, HOWEVER, THE SITE REPORTED THE TERM "CARDIAC". ADDITIONAL INFORMATION HAS BEEN 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 LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death 2.75X28MM TAXUS EXPRESS2 STENT| 2.25X24MM TAXUS EXPRESS2 STENT