BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS ELEMENT PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 3023401 · Received March 27, 2013

    Report

    Report Number
    2134265-2013-01694
    Event Type
    Death
    Date Received
    March 27, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 26, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 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. THE MANUFACTURING BATCH RECORD REVIEW CONFORMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATION AS THE REPORTED EVENT IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE PRODUCT DIRECTIONS FOR USE (DFU) AND/OR DEVICE LABELING. (B)(4).

    Description of Event or Problem · 1

    (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT HAD MYOCARDIAL INFARCTION (MI) AND EXPIRED. IN (B)(6) 2008, THE PATIENT PRESENTED WITH COMPLAINTS OF CHEST PAIN, INCREASED SHORTNESS OF BREATH. THE PATIENT WAS DIAGNOSED WITH STABLE ANGINA (CCS CLASSIFICATION: 2) AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE LONG TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (PROX RCA) EXTENDING TO MID RCA WITH 70% STENOSIS AND WAS 28MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION AND PLACEMENT OF A 2.75X32MM TAXUS PERSEUS STENT, WITH 0% RESIDUAL STENOSIS FOLLOWING POST-DILATION. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2013, THE PATIENT PRESENTED WITH CHEST TIGHTNESS ASSOCIATED WITH INCREASED SHORTNESS OF BREATH RADIATING TO JAW AND WAS HOSPITALIZED ON THE SAME DAY. CARDIAC ENZYMES WERE FOUND TO BE ELEVATED. THE PATIENT WAS DIAGNOSED WITH A NON ST-ELEVATION MYOCARDIAL INFARCTION. NO INTERVENTION WAS PERFORMED AND THE PATIENT WAS TREATED MEDICALLY. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS. DURING THE SAME HOSPITALIZATION THE PATIENT WAS ALSO DIAGNOSED WITH ACUTE KIDNEY IMPAIRMENT (AKI) AND ACUTE RENAL IMPAIRMENT. AT THE TIME OF REPORTING THE EVENT OF AKI IS CONSIDERED NOT RECOVERED/NOT RESOLVED. THE PATIENT WAS DISCHARGED. ONE WEEK LATER, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND WAS HOSPITALIZED ON THE SAME DAY. TWO DAYS LATER, THE PATIENT WAS TRANSFERRED TO ANOTHER MEDICAL FACILITY WITH DIAGNOSIS OF PULMONARY EDEMA. DURING THE SAME HOSPITALIZATION THE PATIENT WAS ALSO DIAGNOSED WITH ACUTE RESPIRATORY DISTRESS SYNDROME AND ACUTE RENAL IMPAIRMENT, DECOMPENSATED CARDIAC FAILURE, AND NON ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI). THE EVENTS WERE CONSIDERED AS NOT RECOVERED/NOT RESOLVED AT THE TIME OF REPORTING. IN (B)(6) 2013, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS "DECOMPENSATED CARDIAC FAILURE". NO AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126240 TAXUS ELEMENT PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK571 11068837

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death| H