BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 4895973 · Received July 7, 2015

    Report

    Report Number
    2134265-2015-04255
    Event Type
    Death
    Date Received
    July 7, 2015
    Date of Event
    May 14, 2014
    Report Date
    June 12, 2015
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE 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 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

    SAME CASE AS MDR ID: 2134265-2015-04254 AND 2134265-2015-04256. (B)(4). IT WAS REPORTED THAT ACUTE RESPIRATORY FAILURE AND DEATH OCCURRED. IN (B)(6) 2012, THE PATIENT PRESENTED DUE TO CHEST PAIN AND WAS HOSPITALIZED ON THE SAME DAY. THE PATIENT WAS DIAGNOSED WITH NON-ST ELEVATION MYOCARDIAL INFARCTION (NSTEMI). SUBSEQUENTLY, CORONARY ANGIOGRAPHY AND INDEX PROCEDURE WERE PERFORMED. THE TARGET LESION #1 WAS LOCATED IN THE PROXIMAL PORTION OF SAPHENOUS VENOUS GRAFT (SVG) TO OBTUSE MARGINAL (OM1) WITH 90% IN-STENT RESTENOSIS OF AN UNKNOWN DRUG ELUTING STENT (DES) AND WAS 32 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.5X38 MM PROMUS ELEMENT¿ PLUS STENT, RESULTING IN 0% RESIDUAL STENOSIS. THE TARGET LESION #2 WAS LOCATED AT THE ANASTOMOTIC SITE IN THE DISTAL PORTION OF SVG TO OM1 WITH 70% IN-STENT RESTENOSIS OF AN UNKNOWN DES AND WAS 8 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.75X12 MM PROMUS ELEMENT¿ PLUS STENT, RESULTING IN 0% RESIDUAL STENOSIS. THE TARGET LESION #3 WAS LOCATED IN THE NATIVE OM1 DISTAL TO THE ANASTOMOTIC SITE WITH 90% IN-STENT RESTENOSIS OF A N UNKNOWN DES AND WAS 16 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50X20MM PROMUS ELEMENT¿ PLUS STENT, RESULTING IN 0% RESIDUAL STENOSIS. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2014, THE PATIENT PRESENTED WITH 1 WEEK HISTORY OF PROGRESSIVE SHORTNESS OF BREATH (SOB), DYSPNEA ON EXERTION AND WAS SUBSEQUENTLY DIAGNOSED WITH ACUTE RESPIRATORY FAILURE SECONDARY TO CONGESTIVE HEART FAILURE (CHF) EXACERBATION. PATIENT'S ELECTROCARDIOGRAM (ECG) REVEALED ATRIAL FIBRILLATION, BIFASCICULAR BLOCK AND NON-SPECIFIC ST AND T WAVE CHANGES AND THE PATIENT HAD ACUTE ON CHRONIC COMBINED SYSTOLIC AND DIASTOLIC CONGESTIVE HEART FAILURE DUE TO ISCHEMIC CARDIOMYOPATHY. PATIENT'S COMPUTED TOMOGRAPHY (CT SCAN) REVEALED BILATERAL PLEURAL EFFUSIONS AND PNEUMONIA DUE TO RIGHT LUNG CONSOLIDATION WHICH PLACED PATIENT ON DOXYCYCLINE AND ROCEPHIN. THE PATIENT ALSO HAD ACUTE RENAL INSUFFICIENCY, POSSIBLY MEETING THE CRITERIA FOR ACUTE RENAL FAILURE WITH CHRONIC KIDNEY DISEASE (CKD) STAGE III/IV AND WAS FOUND TO BE ANEMIC DUE TO CHRONIC DISEASES. ON THE FOLLOWING DAY, AN ECHO WAS PERFORMED WHICH REVEALED MODERATE MITRAL REGURGITATION, TRICUSPID REGURGITATION, PULMONARY HYPERTENSION AND DILATED RIGHT VENTRICLE WITH SEVERELY DEPRESSED RIGHT VENTRICULAR SYSTOLIC FUNCTION. THE PATIENT WAS PLANNED TO BE SENT TO HOSPICE CARE DUE MULTI-SYSTEM ORGAN FAILURE AND ALSO, A DO NOT RESUSCITATE (DNR) WAS INITIATED. PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL ON THE FOLLOWING DAY. FOUR DAYS LATER, THE PATIENT EXPIRED AT HOME AND THE CAUSE OF DEATH IS ACUTE RESPIRATORY FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438139 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493911612270 14967963

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death