BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1954688 · Received January 10, 2011

    Report

    Report Number
    2134265-2010-05723
    Event Type
    Death
    Date Received
    January 10, 2011
    Date of Event
    May 17, 2010
    Report Date
    December 13, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS 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. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT AUTOPSY RESULTS CONFIRMED THAT THERE WAS NO IN STENT RESTENOSIS AND NO STENT THROMBOSIS. PER THE PHYSICIAN "CARDIAC SUDDEN DEATH WOULD OCCUR DUE TO ARRHYTHMIA IN THE STATE OF CHRONIC HEART FAILURE OR DUE TO ACUTE MYOCARDIAL INFARCTION".

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THERE WAS TIMI-3 FLOW PRE AND POST INDEX PROCEDURE. CORE LAB ANALYSIS OF THE LESIONS INDICATED THE TARGET LESION WAS 59% STENOSED PRE PROCEDURE AND 22% STENOSED FOLLOWING TREATMENT. THE PATIENT WAS DISCHARGED 2 DAYS POST INDEX PROCEDURE ON ASPIRIN AND CLOPIDOGREL BISULFATE. 3 DAYS PRIOR TO THE EVENT OF DEATH, A 9 MONTH FOLLOW UP VISIT WAS PERFORMED AND THE ANGINA ASSESSMENT WAS "SILENT ISCHEMIA".

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS MFR ID#: 2134265-2010-05940. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, PATIENT DEATH OCCURRED. THE PATIENT'S PRIMARY DISEASE INCLUDED SILENT ISCHEMIA. THE 90% STENOSED, DE NOVO AND 50MM LONG TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD) WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. THE LESION WAS TREATED WITH DIRECT STENTING USING A 2.5X32MM TAXUS LIBERTE STENT DEPLOYED AT 14ATM AND A 3.5X20MM TAXUS LIBERTE STENT DEPLOYED AT 12ATM. THERE WAS NO GAP BETWEEN THE STENTS. POST DILATION WAS PERFORMED WITH A 3.25X15MM BALLOON AT 10ATM RESULTING IN 0% RESIDUAL STENOSIS. INTRAVASCULAR ULTRASOUND CONFIRMED THE STENTS WERE EXPANDED WELL. HOWEVER SILENT ISCHEMIA WAS STILL PRESENT. THE PATIENT WAS DISCHARGED 2 DAYS LATER. SUBSEQUENT 1 MONTH AND 6 MONTH FOLLOW UP VISITS FOUND THAT THE PATIENT STILL HAD SILENT ISCHEMIA. (B)(6) 2010, THE PATIENT EXPERIENCED CARDIO-RESPIRATORY ARREST AND WAS TRANSPORTED BY AMBULANCE TO THE HOSPITAL. CARDIOPULMONARY RESUSCITATION WAS PERFORMED BUT WAS UNSUCCESSFUL AND THE PATIENT DIED THE SAME DAY.

    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 H7493893632250

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death 3.5X20MM TAXUS LIBERTE STENT