BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 3222292 · Received July 12, 2013

    Report

    Report Number
    2134265-2013-04735
    Event Type
    Death
    Date Received
    July 12, 2013
    Date of Event
    November 16, 2012
    Report Date
    June 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. 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 MDR ID# 2134265-2013-04734; 2134265-2013-04736. (B)(4). IT WAS REPORTED THAT SUBSEQUENT TO A PERCUTANEOUS CORONARY INTERVENTION, THE SUBJECT DIED. ON (B)(6) 2010, THE SUBJECT WAS DIAGNOSED WITH ABNORMAL CV FUNCTION STUDY AND POSITIVE NUCLEAR TEST AND WAS DIAGNOSED WITH SILENT ISCHEMIA AND WAS REFERRED FOR CARDIAC CATHETERIZATION WHICH REVEALED 3 TARGET LESIONS. TARGET LESION #1 WAS A 95% STENOSED AND 10MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.4MM DE NOVO LESION LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY (LCX). THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.75 MM X 12 MM TAXUS LIBERTE STENT. RESIDUAL STENOSIS WAS 0% FOLLOWING POST DILATATION. THE SUBJECT WAS DISCHARGED 2 DAYS AFTER ON ASPIRIN AND PRASUGREL. SIXTEEN DAYS AFTER, THE SUBJECT WAS REFERRED TO THE CATH LAB FOR STENT PLACEMENT. TARGET LESION #2 WAS A 90% STENOSED AND 30MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.9MM DE NOVO LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 MM X 32 MM TAXUS LIBERTE STENT. RESIDUAL STENOSIS WAS 0% FOLLOWING POST DILATATION. TARGET LESION #3 WAS A 90% STENOSED AND WAS 22MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.9MM DE NOVO LESION LOCATED IN THE PROXIMAL RCA. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 MM X 24 MM TAXUS LIBERTE STENT. RESIDUAL STENOSIS WAS 0% FOLLOWING POST DILATATION. THE SUBJECT WAS DISCHARGED A DAY AFTER ON ASPIRIN AND PRASUGREL. ON (B)(6) 2012 THE SUBJECT DIED. AT THE TIME OF EVENT, THE SUBJECT WAS TAKING "OTHER" ANTIPLATELET MEDICATION, CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321545 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493893732250 12887694

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death