BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 3021621 · Received March 26, 2013

    Report

    Report Number
    2134265-2013-02352
    Event Type
    Death
    Date Received
    March 26, 2013
    Date of Event
    April 7, 2012
    Report Date
    February 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS COMBINATION PRODUCT. AGE AT TIME OF EVENT: THE PATIENT WAS BORN IN (B)(6). 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 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

    SAME CASE AS MDR# 2134265-2013-02351. IT WAS REPORTED POST A PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH STENT IMPLANTATION MYOCARDIAL INFARCTION (MI) AND DEATH OCCURRED. THE TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). IT WAS DESCRIBED AS 30MM LONG, WITH A VESSEL DIAMETER OF 3 MM AND 100% STENOSIS. THE LESION WAS TREATED WITH PREDILATION AND IMPLANTATION OF 3.50X32MM AND 3.00X32MM PROMUS ELEMENT STENT. FOLLOWING POST DILATION, THE RESIDUAL STENOSIS WAS 5%. THE PATIENT WAS DISCHARGED SEVEN DAYS LATER ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2012 THE PATIENT DIED. PER DEATH CERTIFICATE THE PRIMARY CAUSE OF DEATH IS MYOCARDIAL INFARCTION AND PER SITE, THE CAUSE OF DEATH IS MYOGENIC HEART FAILURE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT PRESENTED IN (B)(4) 2012 WITH CARDIAC DECOMPENSATION AND WAS NOTED WITH ELEVATED CK-MB AND TROPONIN T VALUES REPORTED AS A MYOCARDIAL INFARCTION. AN ECG WAS PERFORMED (RESULTS NOT PROVIDED). THE PATIENT DID NOT EXPERIENCE ANY ISCHEMIC SYMPTOMS AND NO ACTION WAS TAKEN TO TREAT THIS EVENT. DURING THIS HOSPITALIZATION, THE SUBJECT WAS DIAGNOSED WITH DECOMPENSATED HEART FAILURE, ISCHEMIC CARDIOMYOPATHY WITH SEVERELY REDUCED SYSTOLIC LEFT VENTRICULAR FUNCTION, CHRONIC BRONCHITIS, AORTIC SCLEROSIS, PERSISTENT ATRIAL FIBRILLATION AND CHRONIC VENOUS INSUFFICIENCY. ALSO, THE SUBJECT WAS CONTINUED ON ANTIBIOTIC THERAPY, SWITCHED TO IV DIURETIC THERAPY AND HE EXPERIENCED REGRESSION OF LEG EDEMA BILATERALLY AND REQUIRED OXYGEN THERAPY. FOUR DAYS LATER, THE SUBJECT WAS ALSO DIAGNOSED WITH NITRITE-NEGATIVE URINARY TRACT INFECTION WHICH PROLONGED THE HOSPITALIZATION. MEDICATION WAS GIVEN AND THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS. THE SUBJECT WAS DISCHARGED ABOUT ONE MONTH LATER. IN (B)(6) 2012, THE SUBJECT DIED. PER DEATH CERTIFICATE THE PRIMARY CAUSE OF DEATH IS MYOCARDIAL INFARCTION AND THE ASSOCIATED CAUSES INVOLVED CHRONIC HEART FAILURE, THREE VESSEL CORONARY ARTERY DISEASE, HEART FAILURE, STEMI, PULMONARY FIBROSIS AND CHRONIC BRONCHITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124015 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911332300 0013896769

    Patients

    Seq Age Sex Outcome Treatment
    1 Death