BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 6736930 · Received July 24, 2017

    Report

    Report Number
    2134265-2017-07429
    Event Type
    Injury
    Date Received
    July 24, 2017
    Date of Event
    June 16, 2017
    Report Date
    July 10, 2017
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    UDI-DI
    08714729839972
    PMA / PMN Number
    P150003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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 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# 2134265-2017-07635. IT WAS REPORTED VIA USER/FACILITY MEDWATCH# 5070686 THAT MYOCARDIAL INFARCTION AND STENT THROMBOSIS OCCURRED. THE PATIENT ARRIVED AT THE EMERGENCY ROOM (ER) WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI). THE PATIENT WAS EMERGENTLY TRANSFERRED TO THE CARDIAC CATH LAB (CCL) AND FILMS REVEALED A 90% STENOSED TARGET LESION LOCATED IN THE RIGHT POSTERIOR DESCENDING ARTERY (RPDA). AFTER PRE-DILATATION WAS PERFORMED WITH A 2.5 X 15 EMERGE MR BALLOON CATHETER, TWO SYNERGY II DRUG-ELUTING STENTS, 2.50 X 20 AND 2.50 X 8, WERE DEPLOYED IN OVERLAPPING MANNER WITH GOOD RESULTS. TIMI 3 FLOW AND 0% RESIDUAL STENOSIS WERE CONFIRMED AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS DISCHARGED WITH INSTRUCTIONS FOR ACETYLSALICYLIC ACID (ASA) 81MG, PLAVIX 75MG, AND COUMADIN 5MG, AND TO DISCONTINUE XARELTO. THE PATIENT RETURNED TO THE ER WITH RIGHT FEMORAL PSEUDOANEURYSM WHICH WAS TREATED MEDICALLY. THE PATIENT WAS DISCHARGED WITH INSTRUCTED TO CONTINUE ONLY ASA AND PLAVIX AT THIS TIME DUE TO GROIN COMPLICATIONS. THE PATIENT GOT CONFUSED AT HOME REGARDING THE MEDICATIONS AND TOOK NO MEDICATIONS. THE PATIENT RETURNED AGAIN TO THE ER WITH STEMI. THE PATIENT WAS TAKEN EMERGENTLY TO THE CCL WHERE FILMS REVEALED 100% THROMBOTIC OCCLUSION OF THE PREVIOUSLY PLACED SYNERGY II DRUG-ELUTING STENTS IN THE RPDA. AS TREATMENT, A 2.5 X 15 EMERGE MR BALLOON CATHETER WAS USED TO DILATE THE STENTS IN OVERLAPPING INFLATIONS. TIMI 3 FLOW WAS RESTORED WITH 0% RESIDUAL STENOSIS AND THE PATIENT WAS DISCHARGED WITH INSTRUCTIONS OF ASA 81MG AND BRILINTA 90MG TWICE A DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516911 SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM NIQ BOSTON SCIENTIFIC - GALWAY H7493926008250 20023915 08714729839972

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention