BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 6092081 · Received November 10, 2016

    Report

    Report Number
    2134265-2016-09891
    Event Type
    Injury
    Date Received
    November 10, 2016
    Date of Event
    October 13, 2016
    Report Date
    October 13, 2016
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P150003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. 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 THAT THE PATIENT EXPERIENCED CHEST PAIN AND ST ELEVATION AND STENT THROMBOSIS OCCURRED. THE PATIENT PRESENTED WITH UNSTABLE ANGINA. THE TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY. HEPARIN MEDICATION WAS GIVEN TO THE PATIENT. A 2.25 X 16 SYNERGY II DRUG-ELUTING STENT WAS DEPLOYED TO TREAT THE LESION. THE PROCEDURE WAS COMPLETED AND A DUAL ANTI-PLATELET MEDICATION WAS GIVEN TO THE PATIENT. HOWEVER, APPROXIMATELY TWO HOURS POST PROCEDURE, THE PATIENT WAS BROUGHT BACK TO THE CATH LAB AS ST SEGMENT ELEVATION WAS NOTED WITH SEVERE CHEST PAIN. CORONARY ANGIOGRAPHY WAS PERFORMED WHICH REVEALED 100% OCCLUSION OF THE PREVIOUSLY PLACED STENT WITH THROMBUS. THE ACUTE OCCLUSION WAS TREATED WITH BALLOON ANGIOPLASTY USING A 2.0 X 12MM EMERGE AND A 2.5 X 15MM NC QUANTUM BALLOON CATHETERS. OPTICAL COHERENCE TOMOGRAPHY (OCT) IMAGING WAS PERFORMED WHICH VERIFIED A WELL APPOSED STENT. TEMPORARY PACEMAKER WAS PLACED TO TREAT COMPLETE HEART BLOCK AND SYMPTOMATIC BRADYCARDIA. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS SENT BACK TO HIS ROOM. POST PROCEDURE, THE PATIENT HAD A PAINFUL RIGHT GREAT TOE THAT WAS THOUGHT LIKELY TO BE ISCHEMIC FROM A CHOLESTEROL EMBOLISM DUE TO HIS SECOND CORONARY INTERVENTION. DUE TO AGGRESSIVE ANTIPLATELET THERAPY, THE PATIENT DEVELOPED AN ACUTE GASTRO-INTESTINAL BLEEDING, BUT THE PATIENT DID NOT RECEIVE ANY BLOOD TRANSFUSIONS. SEVEN DAYS LATER, THE PATIENT WAS DISCHARGED HOME IN GOOD CONDITION WITH A VERY GOOD PROGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744231 SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM NIQ BOSTON SCIENTIFIC - GALWAY H7493926016220

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention