BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 6714581 · Received July 14, 2017

    Report

    Report Number
    2134265-2017-06816
    Event Type
    Injury
    Date Received
    July 14, 2017
    Date of Event
    April 17, 2017
    Report Date
    June 20, 2017
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    UDI-DI
    08714729840299
    PMA / PMN Number
    P150003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATION. 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 REPORTED VIA FACILITY MEDWATCH# 5070014 THAT STENT THROMBOSIS AND MYOCARDIAL INFARCTION OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE LONG HEAVILY CALCIFIED MID LEFT ANTERIOR DESCENDING (LAD). AFTER ROTATIONAL ATHERECTOMY WAS PERFORMED, A BALLOON CATHETER AND CUTTING BALLOON WERE SELECTED TO DILATE THE LESION. SUBSEQUENTLY, A 3.0 X 28 SYNERGY MR STENT WAS IMPLANTED WITH GOOD RESULTS. THE PATIENT WAS DISCHARGED ON ASPIRIN (ASA) 81 MG DAILY (QD) AND BRILINTA 90MG TWO TIMES A DAY (BID). FOUR DAYS AFTER AT 11:30, THE PATIENT EXPERIENCED SUDDEN ONSET OF CHEST PAIN. UPON ARRIVAL TO EMERGENCY ROOM (ER), THE PATIENT HAS ST ELEVATION MYOCARDIAL INFARCTION (STEMI). ANGIOGRAPHY REVEALED 100% THROMBOTIC OCCLUSION OF PREVIOUSLY PLACED 3.0 X 28 SYNERGY MR STENT IN MID-LAD. A 2.5 X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION AND TIMI FLOW WAS RESTORE. SUBSEQUENTLY, A 2.5 X 24MM SYNERGY STENT WAS THEN DEPLOYED OVERLAPPING THE DISTAL EDGE OF PREVIOUSLY IMPLANTED 3.0 X 28 SYNERGY MR STENT. POST-DILATION WITH A 3X15MM NC EMERGE BALLOON CATHETER THERE WAS TIMI III FLOW WITH 0% RESIDUAL STENOSIS. ON ADMISSION IT APPEARED THAT PATIENT HAD BEEN COMPLIANT WITH ASA AND BRILINTA BUT UPON FURTHER QUESTIONING PATIENT HAS RUN OUT OF ASA AND HAD CONTINUED BRILINTA ALONE. THE PATIENT DID WELL AND WAS DISCHARGED WITH COUNSELING TO CONTINUE ASA 81MG AND BRILINTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493987 SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM NIQ BOSTON SCIENTIFIC - GALWAY H7493926028300 0020218495 08714729840299

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention