BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 3912766 · Received July 3, 2014

    Report

    Report Number
    2134265-2014-03788
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 5, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    (B)(4) CLINICAL TRIAL. IT WAS REPORTED THAT STENT UNDERDEPLOYMENT OCCURRED. IN (B)(6) 2014, POST STUDY INDEX PROCEDURE, THE SUBJECT PRESENTED WITH SQUEEZING CHEST DISCOMFORT WITH DIAPHORESIS AND WAS HOSPITALIZED ON THE SAME DAY. ADMISSION ECG REVEALED ANTEROSEPTAL MYOCARDIAL INFARCTION, ABNORMAL ECG. TROPONIN VALUE WAS FOUND TO BE ELEVATED. THE SUBJECT WAS DIAGNOSED WITH Q-WAVE, ST SEGMENT ELEVATION MYOCARDIAL INFARCTION AND CARDIAC CATHETERIZATION WAS RECOMMENDED. A TOTAL OCCLUSION IN THE NON-TARGET VESSEL PROXIMAL LAD (LEFT ANTERIOR DESCENDING) WAS TREATED WITH BALLOON ANGIOPLASTY FOLLOWED BY PLACEMENT OF A 3.00 X 32 MM PROMUS ELEMENT PLUS DRUG ELUTING STENT. THE STENT WAS POST DILATED USING A 3.50 X 6 MM QUANTUM BALLOON. IVUS WAS PERFORMED WHICH REVEALED THAT THE PROXIMAL PORTION OF THE 3.00 X 32 MM PROMUS DRUG ELUTING STENT WAS UNDER DEPLOYED. THIS UNDER DEPLOYED STENT WAS FURTHER TREATED WITH BALLOON INFLATIONS USING A 5.00 X 6 MM QUANTUM BALLOON. FURTHER DILATATIONS WERE PERFORMED USING A 3.25 X 20 MM QUANTUM BALLOON THROUGHOUT THE STENT. REPEAT ANGIOGRAPHY REVEALED EXCELLENT RESULTS WITH 100% PATENCY THROUGHOUT AND NORMAL FLOW. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED THREE DAYS POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390518 PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY UNK717

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR