BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 4928661 · Received July 21, 2015

    Report

    Report Number
    2134265-2015-04558
    Event Type
    Death
    Date Received
    July 21, 2015
    Date of Event
    June 21, 2015
    Report Date
    June 23, 2015
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT IN (B)(6) 2015, ANGIOGRAPHY WAS PERFORMED WITHOUT REVASCULARIZATION. TWELVE DAYS AFTER, THE PATIENT ALSO PRESENTED EMERGENTLY SEVERE DYSELECTROLYTEMIA AND HYPOCALCEMIA. THE PATIENT WAS STARTED ON CALCIUM CARBONATE, DILTIAZEM, HEPARIN AND CARDIZEM DRIPS. TROPONIN LEVELS WERE NOTED TO BE ELEVATED WHILE ELECTROCARDIOGRAPHY SHOWED ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RATE, LEFT AXIS DEVIATION, LOW VOLTAGE IN FRONTAL LEADS AND REPOLARIZATION ABNORMALITY. IT WAS NOTED THAT THE PATIENT HAD BEEN NON-COMPLIANT WITH MEDICATIONS THE PREVIOUS FEW DAYS, AS A RESULT OF WHICH THE PATIENT HAD DIFFICULTY IN BREATHING, WEAKNESS, UNSTEADY GAIT AND ENDED UP HAVING A FALL. FOUR DAYS LATER, THE PATIENT HAD A CARDIAC ARREST AND WAS RESPONSIVE UPON RESUSCITATION WITH ADVANCED CARDIAC LIFE SUPPORT (ACLS) PROTOCOL. AFTER THE CARDIAC ARREST, THE PATIENT WAS NOTED TO BE BRADYCARDIC AND WAS SUBSEQUENTLY PLACED ON DOPAMINE, EPINEPHRINE AND TRANSCUTANEOUS PACING. THE NEXT DAY THE PATIENT WAS DIAGNOSED WITH PNEUMONIA AND CARDIOGENIC SHOCK NOT RELATED TO THE DEVICE. IT WAS DECIDED TO PLACE THE PATIENT ON COMFORT CARE MEASURES ONLY AND SUBSEQUENTLY DO NOT RESUSCITATE (DNR) WAS INITIATED. A DAY AFTER, THE PATIENT DIED. THE PRIMARY CAUSE OF DEATH WAS ATRIAL FIBRILLATION AND NOT CONSIDERED TO BE RELATED TO THE DEVICE. AUTOPSY WAS NOT PERFORMED.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2015-04559 (B)(6) IT WAS REPORTED THAT PATIENT DEATH OCCURRED. IN (B)(6) 2012, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA. SUBSEQUENTLY, CORONARY ANGIOGRAPHY AND INDEX PROCEDURE WERE PERFORMED. THE TARGET LESION WAS A DE NOVO LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA) WITH 95% STENOSIS AND WAS 38MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25MM. THE LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF A 2.25X24MM AND A 2.50X16MM PROMUS ELEMENT¿ PLUS STENTS IN AN OVERLAPPING MANNER, WITH 0% RESIDUAL STENOSIS. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2015, THE PATIENT PRESENTED WITH ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RATE AND WAS HOSPITALIZED ON THE SAME DAY. NO ACTION WAS TAKEN FOR THIS EVENT AND WAS CONSIDERED RESOLVING. FIVE DAYS FROM HOSPITALIZATION, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. HOWEVER ON THE SAME DAY, THE PATIENT EXPIRED DUE TO CARDIAC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471923 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493911424220 15397421

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death