BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 6107272 · Received November 16, 2016

    Report

    Report Number
    2134265-2016-10073
    Event Type
    Death
    Date Received
    November 16, 2016
    Date of Event
    October 13, 2016
    Report Date
    October 18, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE 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).

    Description of Event or Problem · 1

    (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT MYOCARDIAL INFARCTION (MI) AND DEATH OCCURRED. IN (B)(6) 2012, THE PATIENT WAS DIAGNOSED WITH MYOCARDIAL INFARCTION AND SILENT ISCHEMIA. SUBSEQUENTLY, THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION AND INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION WAS A DE NOVO LESION LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX (LCX) ARTERY WITH 100% STENOSIS AND WAS 20MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.50MMX28MM PROMUS ELEMENT" PLUS DRUG ELUTING-STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. FOUR DAYS AFTER, THE PATIENT WAS DISCHARGE WITH ASPIRIN AND PRASUGREL. IN (B)(6) 2016, THE PATIENT ARRIVED IN THE EMERGENCY ROOM WITH CHEST PAIN AND WAS DESCRIBED AS PRESSURE, TIGHTNESS AND ACHING LOCATED IN THE CENTRAL AND LEFT CHEST AREA. SEVERITY WAS DESCRIBED AS 10/10. IT GOT MODIFIED WITH COUGH AND DEEP BREATHS. THE PATIENT HAD DIFFICULTY IN BREATHING, NAUSEA AND DIAPHORESIS. ECG REVEALED ABNORMAL RHYTHM, ATRIAL FIBRILLATION, WIDE QRS AND ST ELEVATION IN LEAD II, III AND "AVF." CARDIAC ENZYME WAS NOT NOTED TO BE ELEVATED AND THE SITE REPORTED AN EVENT OF MI. THE PATIENT EXPERIENCED VENTRICULAR TACHYCARDIA, NOTED TO HAVE WEAK PULSE AND RESPIRATION. FOLLOWING WHICH THE PATIENT WAS DEFIBRILLATED, VENTILATED AND CHEST COMPRESSIONS WERE PERFORMED. SUBSEQUENTLY THE PATIENT RECEIVED CRITICAL CARE INCLUDING EXTERNAL PACEMAKER PLACEMENT AND CARDIOPULMONARY RESUSCITATION (CPR) IN PROGRESS. HOWEVER, SYMPTOMS GOT WORSE AND DECISION WAS MADE TO STOP ALL EFFORTS. AT 7:32 THE PATIENT DIED. THE CAUSE OF DEATH STATED AS "ACUTE MYOCARDIAL INFARCTION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758911 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493911428350 15182032

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death| R