BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 5785140 · Received July 12, 2016

    Report

    Report Number
    2134265-2016-05956
    Event Type
    Death
    Date Received
    July 12, 2016
    Report Date
    June 15, 2016
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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 REPORTED THAT THE PATIENT DIED. IN (B)(6) 2009, INDEX PROCEDURE WAS PERFORMED. THE 97.4% STENOSED, DE NOVO TARGET LESION WAS LOCATED IN THE RIGHT POSTERIOR ATRIOVENTRICULAR (R-PAV) SEGMENT. FOLLOWING PRE-DILATION, A NON-BSC STENT WAS DEPLOYED AND POST-DILATION WAS THEN PERFORMED. CORONARY ANGIOGRAPHY WAS PERFORMED AND CONFIRMED THE RESIDUAL STENOSIS RATE AS 0%. A 16 X 3.00MM TAXUS LIBERTE DRUG-ELUTING STENT WAS DEPLOYED, AND AFTER THAT, THE DEPLOYMENT OF ANOTHER NON-BSC STENT WAS ATTEMPTED IN THE 25% STENOSED LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) BUT THE STENT DISLODGED DUE TO SEVERE CALCIFICATION. A NON-BSC STENT WAS DEPLOYED IN THE PROXIMAL RCA AND THE DISLODGED STENT WAS ADHERED TO THE BLOOD VESSEL. RESIDUAL STENOSIS RATE WAS CONFIRMED AS 0%. THE FOLLOWING DAY, THE PATIENT WAS DISCHARGE FROM THE HOSPITAL. IN (B)(6) 2010, THE PATIENT HAD FOLLOW-UP CORONARY ANGIOGRAPHY, AND 50% RESTENOSIS WAS CONFIRMED IN THE R-PAV SEGMENT AND 90% RESTENOSIS IN THE PROXIMAL RCA. THE PATIENT WAS THEN SCHEDULED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI) TWO WEEKS AFTER. HOWEVER, THE PATIENT'S FAMILY REPORTED THAT THE PATIENT WAS ADMITTED TO THE OTHER MEDICAL FACILITY. THE PATIENT DID NOT VISIT THE HOSPITAL SINCE THEN, AND HIS CONDITION BECAME UNTRACEABLE. IN (B)(6) 2011, THE HOSPITAL FOUND THAT THE PATIENT HAD DIED WHEN THEY CONTACTED TO THE PATIENT'S SURETY. DETAILED INFORMATION SUCH AS THE DATE AND THE CAUSE OF DEATH ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440432 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493893616300

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death