BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY XD

    MDR report key: 15160966 · Received August 3, 2022

    Report

    Report Number
    2134265-2022-08343
    Event Type
    Injury
    Date Received
    August 3, 2022
    Date of Event
    April 6, 2022
    Report Date
    January 5, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AGENT IDE STUDY: IT WAS REPORTED THAT MYOCARDIAL INFARCTION AND RESTENOSIS OCCURRED. ON (B)(6) 2021, THE SUBJECT EXPERIENCED UNSTABLE ANGINA. ON (B)(6) 2022, A 2.50 X 20MM SYNERGY STENT WAS IMPLANTED IN THE DISTAL RAMUS TO TREAT THE UNSTABLE ANGINA. ON (B)(6) 2022, THE SUBJECT PRESENTED TO THE HOSPITAL WITH COMPLAINT OF CHEST PRESSURE AND WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT. ON THE SAME DAY, TROPONIN WAS NOTED TO BE ELEVATED AND THE SUBJECT WAS DIAGNOSED WITH MYOCARDIAL INFARCTION. AT THE TIME OF THE EVENT, THE SUBJECT WAS ON ASPIRIN AND CLOPIDOGREL. DURING THE COURSE OF HOSPITALIZATION, THE SUBJECT WAS TREATED WITH ASPIRIN AND WAS STARTED ON A HEPARIN DRIP. ON (B)(6) 2022, DIAGNOSTIC CORONARY ANGIOGRAPHY REVEALED A HIGH GRADE 90% RESTENOSIS AT THE DISTAL RAMUS, IN THE INFERIOR BRANCH OF THE VESSEL. ON THE SAME DAY, THE 90% STENOSIS WAS TREATED WITH BALLOON ANGIOPLASTY USING 1.5 MM X 12 MM AND 2.0 MM X 12 MM NON BOSTON SCIENTIFIC BALLOONS. POST REVASCULARIZATION, 30% RESIDUAL STENOSIS WAS NOTED WITH TIMI FLOW 3. THE NEXT DAY, THE EVENT WAS CONSIDERED RECOVERED/RESOLVED AND THE SUBJECT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY (DAPT).

    Description of Event or Problem · 0

    AGENT IDE STUDY. IT WAS REPORTED THAT MYOCARDIAL INFARCTION AND RESTENOSIS OCCURRED. ON (B)(6) 2021, THE SUBJECT EXPERIENCED UNSTABLE ANGINA AND A 2.50 X 20MM SYNERGY STENT WAS IMPLANTED IN THE DISTAL RAMUS. ON (B)(6) 2022, 205 DAYS POST INDEX PROCEDURE, THE SUBJECT PRESENTED TO THE HOSPITAL WITH COMPLAINT OF CHEST PRESSURE AND WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT. ON THE SAME DAY, TROPONIN WAS NOTED TO BE ELEVATED AND THE SUBJECT WAS DIAGNOSED WITH MYOCARDIAL INFARCTION. AT THE TIME OF THE EVENT, THE SUBJECT WAS ON ASPIRIN AND CLOPIDOGREL. DURING THE COURSE OF HOSPITALIZATION, THE SUBJECT WAS TREATED WITH ASPIRIN AND WAS STARTED ON A HEPARIN DRIP. ON (B)(6) 2022, DIAGNOSTIC CORONARY ANGIOGRAPHY REVEALED A HIGH GRADE 90% RESTENOSIS AT THE DISTAL RAMUS, IN THE INFERIOR BRANCH OF THE VESSEL. ON THE SAME DAY, THE 90% STENOSIS WAS TREATED WITH BALLOON ANGIOPLASTY USING 1.5 MM X 12 MM AND 2.0 MM X 12 MM NON BOSTON SCIENTIFIC BALLOONS. POST REVASCULARIZATION, 30% RESIDUAL STENOSIS WAS NOTED WITH TIMI FLOW 3. THE NEXT DAY, THE EVENT WAS CONSIDERED RECOVERED/RESOLVED AND THE SUBJECT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY (DAPT). IT WAS FURTHER REPORTED THAT ON (B)(6) 2022, THE SUBJECT PRESENTED EMERGENTLY WITH COMPLAINTS OF CHEST PAIN WITH SHORTNESS OF BREATH AND DIAPHORESIS. THE SUBJECT HAD BEEN EXPERIENCING EPISODES OF SUDDEN CHEST PAIN WITH SHORTNESS OF BREATH FOR THE PREVIOUS TWO DAYS (3 EPISODES), WHICH WERE RELIEVED WITH NITROGLYCERINE. THE CURRENT EPISODE WAS DESCRIBED AS WORSE THAN THE PREVIOUS EPISODES AND HENCE THE SUBJECT WAS BROUGHT TO THE HOSPITAL. ON ARRIVAL AT THE EMERGENCY DEPARTMENT, THE CHEST PAIN HAD RESOLVED, AND THE SUBJECT WAS HEMODYNAMICALLY STABLE. A CHEST X-RAY WAS NEGATIVE FOR ACUTE CARDIOPULMONARY ABNORMALITIES. AT THE TIME OF THE EVENT, THE SUBJECT WAS ALSO ON APIXABAN. THE SUBJECT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR FURTHER EVALUATION AND THE TREATMENT WHICH OCCURRED ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2079702 SYNERGY XD CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention