BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 16811390 · Received April 25, 2023

    Report

    Report Number
    2124215-2023-19878
    Event Type
    Injury
    Date Received
    April 25, 2023
    Date of Event
    November 14, 2019
    Report Date
    April 25, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AGENT IDE STUDY. IT WAS REPORTED THAT IN-STENT RESTENOSIS (ISR) OCCURRED. ON (B)(6) 2018 STENOSIS IN THE DISTAL RIGHT CORONARY ARTERY (RCA) WAS TREATED WITH A 4.00 X 12 SYNERGY DRUG ELUTING STENT AND STENOSIS IN THE DIAGONAL WAS TREATED WITH A 2.75 X 12 SYNERGY DRUG ELUTING STENT. ON (B)(6) 2019, 44% ISR IN THE DISTAL RCA WAS TREATED WITH A 3.50 X 6MM NC QUANTUM APEX BALLOON AND 61% ISR OF THE PREVIOUSLY PLACED 2.75 X 12MM SYNERGY STENT PLACED IN THE DIAGONAL WAS TREATED WITH A 3.25 X 6MM NC QUANTUM APEX BALLOON. ADDITIONALLY 52% ISR IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WAS TREATED WITH A 4.50 X 6MM NC QUANTUM APEX BALLOON. ON (B)(6) 2020, ISR IN THE MID LAD WAS TREATED WITH A 3.25 AND 3.50 X 20 MM NC QUANTUM APEX BALLOON AND ISR AT THE DIAGONAL WAS TREATED WITH A 3.25 AND 3.50 X 20MM NC QUANTUM APEX BALLOON. ON (B)(6) 2022, THE SUBJECT PRESENTED EMERGENTLY WITH THE COMPLIANT OF CHEST PAIN AND SHORTNESS OF BREATH, WHICH HAD BEEN PROGRESSING SINCE LAST NIGHT AND GOT BETTER WITH REST. THE SUBJECT WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT. AT THE TIME OF EVENT THE SUBJECT WAS ON ASPIRIN AND CLOPIDOGREL. IN THE EMERGENCY DEPARTMENT, THE SUBJECT STARTED TO HAVE CHEST TIGHTNESS WHICH GOT RESOLVED WITH REST AND SUBLINGUAL NITROGLYCERIN. A CARDIOLOGIST WAS CONSULTED AND CARDIAC CATHETERIZATION PLANNED. FOLLOWING ANGIOGRAPHY WHICH REVEALED 99% OSTIAL IN-STENT RESTENOSIS OF THE 2ND DIAGONAL, ECHOCARDIOGRAPHY, AND ELECTROCARDIOGRAPHY, THE SUBJECT WAS DIAGNOSED WITH NON-ST ELEVATION MYOCARDIAL INFARCTION ASSOCIATED WITH TARGET LESION THROMBOSIS. THE SAME DAY, PRE-DILATION WAS PERFORMED FROM THE DISTAL LAD TO THE 2ND DIAGONAL USING A 2.25 MM X 8 MM EMERGE BALLOON AND AN UNSPECIFIED 3.00 MM X 12 MM BALLOON. A NON-BOSTON SCIENTIFIC 3.5 MM X 15 MM DRUG ELUTING STENT WAS DEPLOYED, AND POST DILATION WAS PERFORMED WITH 4.00 MM X 10 MM NC BALLOON. POST REVASCULARIZATION, RIGHT GROIN HEMATOMA, HEMORRHAGIC SHOCK, IATROGENIC COAGULOPATHY AND PROLONG QT WERE NOTED AND CAUSED PROLONGATION OF HOSPITALIZATION. FLUIDS AND VASOPRESSORS WERE GIVEN TO TREAT RIGHT GROIN HEMATOMA. FLUIDS, VASOACTIVE MEDICATIONS WERE GIVEN, AND BLOOD TRANSFUSION WAS PERFORMED TO TREAT THE HEMORRHAGIC CHOCK AND IATROGENIC COAGULOPATHY. NON-TARGET VESSEL REVASCULARIZATION WAS PERFORMED TO TREAT THE PROLONGED QT. THREE DAYS LATER THE EVENT WAS CONSIDERED RESOLVED AND THE SUBJECT DISCHARGED ON DUAL ANTIPLATELET THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540775 SYNERGY BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM NIQ BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention| H