BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 2993010 · Received March 7, 2013

    Report

    Report Number
    2134265-2013-01217
    Event Type
    Death
    Date Received
    March 7, 2013
    Date of Event
    January 11, 2013
    Report Date
    February 8, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATION AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT IN (B)(6) 2013 THE PATIENT WAS FOUND TO BE UNRESPONSIVE AND WAS SEEN IN THE EMERGENCY ROOM. THE PATIENT WAS DEHYDRATED, HYPOTENSIVE AND HYPOGLYCEMIC AND WAS DIAGNOSED WITH HYPERKALEMIA, HYPONATREMIA, WORSENING OF DIABETES MELLITUS AND TRANSAMINITIS SECONDARY TO LIVER SHOCK. THE PATIENT WAS HOSPITALIZED ON THE SAME DAY. PANCULTURE WAS ADVISED AND THE SOURCE OF INFECTION WAS SECONDARY TO SEVERE NECROTIC WOUND INFECTION IN GROIN, PERINEAL REGION, SACRAL REGION AND GLUTEAL REGION. THE PATIENT WAS DIAGNOSED WITH WORSENING OF WOUNDS. THE PATIENT WAS ADVISED FOR DEBRIDEMENT OF WOUNDS AFTER SUBJECT STABILIZED MEDICALLY. THE PATIENT WAS TREATED WITH IV FLUIDS AND MEDICATION. THE PATIENT EXPERIENCED BRADYCARDIA AND WENT INTO ASYSTOLE. THE PATIENT WAS INTUBATED AND CPR WAS PERFORMED, HOWEVER HE COULD NOT BE RESUSCITATED AND WAS PRONOUNCED DECEASED ON THE SAME DAY. THE SEPTIC SHOCK AND DEATH AND ARE UNRELATED TO THE TAXUS LIBERTE DEVICE.

    Description of Event or Problem · 1

    (B)(4) CLINICAL TRIAL. IT WAS REPORTED THAT SUBSEQUENT TO A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPIRED. THE PATIENT PRESENTED WITH CLASS 2 STABLE ANGINA AND Q-WAVE NON-ST ELEVATION MYOCARDIAL INFARCTION IN (B)(6) 2010 AND UNDERWENT A CARDIAC CATHETERIZATION PROCEDURE WHICH REVEALED 1 TARGET LESION. THE DE NOVO AND 90% STENOSED TARGET LESION WAS LOCATED IN THE DISTAL LEFT CIRCUMFLEX (LCX) ARTERY WITH A REFERENCE VESSEL DIAMETER OF 2.75MM AND A LESION LENGTH OF 10MM. A 2.75X20MM TAXUS LIBERTE STENT DELIVERY SYSTEM WAS ADVANCED TO THE LCX AND DEPLOYED RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY ON ASPIRIN AND PRASUGREL. IN (B)(6) 2013 THE PATIENT WAS HOSPITALIZED AND EXPIRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98267 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893620270 13154433

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death