BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 10680071 · Received October 14, 2020

    Report

    Report Number
    2134265-2020-13743
    Event Type
    Injury
    Date Received
    October 14, 2020
    Date of Event
    July 6, 2020
    Report Date
    October 14, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    SAME CASE AS PR ID# (B)(4). SYNERGY CHINA REGISTRY. IT WAS REPORTED THAT ACUTE CORONARY SYNDROME OCCURRED. IN (B)(6) 2019, THE SUBJECT PRESENTED WITH UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, INDEX PROCEDURE WAS PERFORMED WHICH REVEALED TARGET LESION #1 WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY EXTENDING TO 1ST DIAGONAL WITH 95% STENOSIS AND WAS 14 MM LONG AND A REFERENCE VESSEL DIAMETER OF 2.25 MM. TARGET LESION #1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.25 MM X 16 MM AND A 3MM X 16 MM SYNERGY DRUG-ELUTING STENT (DES). FOLLOWING THIS INTERVENTION, POST DILATION WAS PERFORMED WITH 0% RESIDUAL STENOSIS. TARGET LESION #2 WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) EXTENDING TO PROXIMAL RCA WITH 95% STENOSIS AND WAS 20 MM LONG AND A REFERENCE VESSEL DIAMETER OF 2.75 MM. TARGET LESION #2 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.00 MM X 16 MM AND A 2.75 MM X 38 MM SYNERGY DES. FOLLOWING THIS INTERVENTION, POST DILATION WAS PERFORMED WITH 0% RESIDUAL STENOSIS. FOUR DAYS LATER, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2020, 315 DAYS POST INDEX PROCEDURE, THE SUBJECT PRESENTED WITH SYMPTOMS OF ACUTE CORONARY SYNDROME AND WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT. NO OTHER ACTION WAS TAKEN TO TREAT THIS EVENT. TWENTY-TWO DAYS LATER, THE EVENT WAS CONSIDERED RECOVERED/RESOLVED AND THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IT WAS FURTHER REPORTED THAT THE TARGET LESION #1 WAS LOCATED IN PROXIMAL LAD TO MID LAD WITH 99% STENOSIS. THE STENT USED WAS A 2.75 MMX16 MM SYNERGY STENT SYSTEM INSTEAD OF 3 MMX16 MM AS PREVIOUSLY REPORTED. IN (B)(6) 2020, THE SUBJECT WAS DIAGNOSED WITH ACUTE CORONARY SYNDROME AND ANGIOGRAPHY REVEALED 80% STENOSIS IN PROXIMAL TO MID LAD. THE RATIONALE FOR TARGET VESSEL REVASCULARIZATION (TVR) WERE ELECTROCARDIOGRAM (ECG) CHANGES AND ANGIOGRAPHIC FINDING WITHOUT SYMPTOMS OR OBJECTIVE SIGNS OF ISCHEMIA. IN (B)(6) 2020, 70% STENOSIS NOTED IN PROXIMAL LAD EXTENDING UP TO MID LAD WAS TREATED WITH PERCUTANEOUS CORONARY INTERVENTION. POST INTERVENTION, RESIDUAL STENOSIS WAS 0% TVR. THE PHYSICIAN CONSIDERS THE EVENT NOT RELATED TO THE STUDY DEVICE.

    Description of Event or Problem · 0

    SAME CASE AS PR ID# (B)(4), (B)(6) IT WAS REPORTED THAT ACUTE CORONARY SYNDROME OCCURRED. IN (B)(6) 2019, THE SUBJECT PRESENTED WITH UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, INDEX PROCEDURE WAS PERFORMED WHICH REVEALED TARGET LESION #1 WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY EXTENDING TO 1ST DIAGONAL WITH 95% STENOSIS AND WAS 14 MM LONG AND A REFERENCE VESSEL DIAMETER OF 2.25 MM. TARGET LESION #1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.25 MM X 16 MM AND A 3MM X 16 MM SYNERGY DRUG-ELUTING STENT (DES). FOLLOWING THIS INTERVENTION, POST DILATION WAS PERFORMED WITH 0% RESIDUAL STENOSIS. TARGET LESION #2 WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) EXTENDING TO PROXIMAL RCA WITH 95% STENOSIS AND WAS 20 MM LONG AND A REFERENCE VESSEL DIAMETER OF 2.75 MM. TARGET LESION #2 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.00 MM X 16 MM AND A 2.75 MM X 38 MM SYNERGY DES. FOLLOWING THIS INTERVENTION, POST DILATION WAS PERFORMED WITH 0% RESIDUAL STENOSIS. FOUR DAYS LATER, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2020, 315 DAYS POST INDEX PROCEDURE, THE SUBJECT PRESENTED WITH SYMPTOMS OF ACUTE CORONARY SYNDROME AND WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT. NO OTHER ACTION WAS TAKEN TO TREAT THIS EVENT. TWENTY-TWO DAYS LATER, THE EVENT WAS CONSIDERED RECOVERED/RESOLVED AND THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IT WAS FURTHER REPORTED THAT THE TARGET LESION #1 WAS LOCATED IN PROXIMAL LAD TO MID LAD WITH 99% STENOSIS. THE STENT USED WAS A 2.75 MMX16 MM SYNERGY STENT SYSTEM INSTEAD OF 3 MMX16 MM AS PREVIOUSLY REPORTED. IN JULY 2020, THE SUBJECT WAS DIAGNOSED WITH ACUTE CORONARY SYNDROME AND ANGIOGRAPHY REVEALED 80% STENOSIS IN PROXIMAL TO MID LAD. THE RATIONALE FOR TCR WERE ECG CHANGES AND ANGIOGRAPHIC FINDING WITHOUT SYMPTOMS OR OBJECTIVE SIGNS OF ISCHEMIA. IN (B)(6) 2020, 70% STENOSIS NOTED IN PROXIMAL LAD EXTENDING UP TO MID LAD WAS TREATED WITH PERCUTANEOUS CORONARY INTERVENTION. POST INTERVENTION, RESIDUAL STENOSIS WAS 0% TARGET-VESSEL REVASCULARIZATION (TVR). THE PHYSICIAN CONSIDERS THE EVENT NOT RELATED TO THE STUDY DEVICE. IT WAS FURTHER REPORTED THAT THE TARGET LESION 1 WAS 27MM LONG INSTEAD OF 14MM AND THE TARGET LESION 2 WAS 47MM LONG INSTEAD OF 20MM AS PREVIOUSLY REPORTED. THE PHYSICIAN CONSIDERS THE ACS EVENT IN (B)(6) 2020 AS POSSIBLY RELATED TO THE STUDY DEVICE.

    Description of Event or Problem · 1

    SAME CASE AS PR ID#: (B)(4). (B)(6) REGISTRY. IT WAS REPORTED THAT ACUTE CORONARY SYNDROME OCCURRED. IN (B)(6) 2019, THE SUBJECT PRESENTED WITH UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, INDEX PROCEDURE WAS PERFORMED WHICH REVEALED TARGET LESION #1 WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY EXTENDING TO 1ST DIAGONAL WITH 95% STENOSIS AND WAS 14 MM LONG AND A REFERENCE VESSEL DIAMETER OF 2.25 MM. TARGET LESION #1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.25 MM X 16 MM AND A 3MM X 16 MM SYNERGY DRUG-ELUTING STENT (DES). FOLLOWING THIS INTERVENTION, POST DILATION WAS PERFORMED WITH 0% RESIDUAL STENOSIS. TARGET LESION #2 WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) EXTENDING TO PROXIMAL RCA WITH 95% STENOSIS AND WAS 20 MM LONG AND A REFERENCE VESSEL DIAMETER OF 2.75 MM. TARGET LESION #2 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.00 MM X 16 MM AND A 2.75 MM X 38 MM SYNERGY DES. FOLLOWING THIS INTERVENTION, POST DILATION WAS PERFORMED WITH 0% RESIDUAL STENOSIS. FOUR DAYS LATER, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2020, 315 DAYS POST INDEX PROCEDURE, THE SUBJECT PRESENTED WITH SYMPTOMS OF ACUTE CORONARY SYNDROME AND WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT. NO OTHER ACTION WAS TAKEN TO TREAT THIS EVENT. TWENTY-TWO DAYS LATER, THE EVENT WAS CONSIDERED RECOVERED/RESOLVED AND THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1141776 SYNERGY CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC CORPORATION 10618 0023580979

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| O| R