BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3163213 · Received June 11, 2013

    Report

    Report Number
    2134265-2013-03941
    Event Type
    Death
    Date Received
    June 11, 2013
    Date of Event
    February 10, 2013
    Report Date
    May 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM -UPDATED. RELEVANT TESTS/LAB DATA AND OTHER RELEVANT HISTORY- CORRECTED AND UPDATED (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: DEVICE HAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS 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 HOSPITALIZED DUE TO MULTIPLE CO-MORBIDITIES AND URINARY RETENTION. THE PATIENT WAS GIVEN MEDICATION TO TREAT THE MULTIPLE COMORBIDITIES. IN (B)(6) 2013, THE PATIENT EXPERIENCED HYPOXEMIA WHICH WAS LATER DIAGNOSED AS CARDIOPULMONARY ARREST. FURTHERMORE, IT WAS REPORTED THAT SECONDARY CAUSES OF DEATH WERE VENTRICULAR FIBRILLATION, ACUTE KIDNEY INJURY, CARDIOMYOPATHY, HYPONATREMIA, CAD AND URINARY RETENTION.

    Description of Event or Problem · 1

    (B)(4) STUDY. SAME CASE AS: MDR ID 2134265-2013-03943. IT WAS REPORTED THAT FOLLOWING A PERCUTANEOUS CORONARY INTERVENTION, THE PATIENT DIED. ON (B)(6) 2013, THE PATIENT EXPERIENCED SHORTNESS OF BREATH AND WAS HOSPITALIZED. CARDIAC CATHETERIZATION WAS RECOMMENDED. EIGHT DAYS POST ADMISSION, THE PATIENT UNDERWENT CORONARY ANGIOGRAPHY WHICH REVEALED A 99% STENOSED, DE-NOVO LESION LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY WITH A LESION LENGTH OF 18 MM LONG AND A REFERENCE VESSEL DIAMETER OF 3.25 MM. THIS WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 3.00 X 20 MM AND 2.50 X 20 MM PROMUS ELEMENT PLUS STENTS. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. AT 16 DAYS POST INDEX PROCEDURE, THE PATIENT WAS PRONOUNCED DEAD. THE PRIMARY CAUSE OF DEATH WAS CARDIOPULMONARY ARREST.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT PRIOR TO INDEX PROCEDURE, THE PATIENT ARRIVED IN HOSPITAL VIA EMERGENCY MEDICAL SERVICES (EMS) IN CARDIO PULMONARY ARREST SECONDARY TO ATRIAL FIBRILLATION (A-FIB) WITH AUTOMATIC IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (AICD) DISCHARGE. THE DEVICE WAS RE-PROGRAMMED AND BATTERY WAS REPLACED. CARDIAC CATHETERIZATION WAS DELAYED DUE TO RENAL INSUFFICIENCY AND NEED FOR ANTI-ARRHYTHMIC THERAPY. DESPITE TWO DAYS OF THERAPY, THE PATIENT'S VENTRICULAR ARRHYTHMIAS PERSISTED. POST PROCEDURE, THE PATIENT WAS STARTED ON ASPIRIN AND PLAVIX. PATIENT'S HOSPITALIZATION WAS PROLONGED DUE TO RENAL INSUFFICIENCY AND PERSISTENT VENTRICULAR ARRHYTHMIAS. THREE DAYS POST INDEX PROCEDURE, THE MULTIPLE COMORBIDITIES WHICH WAS PREVIOUSLY REPORTED NOW INCLUDED VENTRICULAR FIBRILLATION (V-FIB), CONGESTIVE HEART FAILURE, CORONARY ARTERY DISEASE, CARDIOMYOPATHY AND CHRONIC KIDNEY DISEASE. PATIENT WAS ALSO DIAGNOSED WITH ACUTE KIDNEY INJURY WITH URINARY RETENTION AND DYSPHAGIA DURING NEPHROLOGY CONSULTATION. THE PATIENT WAS THEN TREATED FOR URINARY TRACT INFECTION (UTI). ON THE FOLLOWING DAY, THE PATIENT'S AICD FIRED 4 TIMES AND THE PATIENT COMPLAINED OF PALPITATIONS ASSOCIATED WITH SHORTNESS OF BREATH (SOB) AND CHEST TENDERNESS/PRESSURE. CARDIAC MONITOR SHOWED SEVERAL RUNS OF V-FIB, A-FIB AND VENTRICULAR TACHYCARDIA (VT). SIX DAYS POST INDEX PROCEDURE, CT SCAN OF THE CHEST REVEALED MULTILOBAR PNEUMONIA AND WAS TREATED WITH INTRAVENOUS (IV) AND INJECTABLE ANTIBIOTICS. DURING THE PATIENT'S HOSPITAL STAY, PATIENT ACQUIRED (B)(6) AND CLOSTRIDIUM DIFFICILE COLITIS. IN (B)(6) 2013, THE PATIENT WAS ADMITTED TO INTENSIVE CARE UNIT (ICU) FOR RESPIRATORY FAILURE FROM SEVERE ASPIRATION PNEUMONIA, SEPTIC SHOCK AND PATIENT WAS INTUBATED FOR FULL AUTOMATED MECHANICAL VENTILATION (AMV). A LARGE NEW PNEUMONIA ON THE LEFT LOBE WAS NOTED ON THE FOLLOWING DAY AND PATIENT WAS UNABLE TO BE WEANED FROM VENTILATOR SUPPORT DUE TO SEVERE HYPOXEMIA AND POOR FUNCTIONAL STATUS. THE PATIENT'S FAMILY WAS MADE AWARE OF POOR PROGNOSIS AND CODE STATUS DO NOT RESUSCITATE (DNR) WAS MADE. SUBSEQUENTLY, THE PATIENT WAS TERMINALLY EXTUBATED. IN ADDITION, THE CAUSE OF DEATH WAS ALSO ACUTE ASPIRATION PNEUMONIA, SEPTIC SHOCK AND END STAGE SYSTOLIC CONGESTIVE HEART FAILURE (CHF) AND MULTIPLE COMORBIDITIES. DEATH CERTIFICATE IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264024 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911420250 15550336

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death