BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNERGY

    MDR report key: 12911533 · Received December 1, 2021

    Report

    Report Number
    2134265-2021-15150
    Event Type
    Death
    Date Received
    December 1, 2021
    Date of Event
    May 4, 2021
    Report Date
    December 20, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    (B)(6) REGISTRY. IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2020, THE SUBJECT PRESENTED WITH SYMPTOMS OF SILENT ISCHEMIA AND STABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION 1 WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH 99% STENOSIS AND WAS 21 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.7 MM. THE TARGET LESION 1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.00 MM X 24 MM SYNERGY CHINA REGISTRY STENT SYSTEM. FOLLOWING POST DILATION, THE RESIDUAL STENOSIS WAS 0%. THE TARGET LESION 2 WAS LOCATED IN PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY EXTENDING UP TO MID LAD WITH 99% STENOSIS AND WAS 65 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM. THE TARGET LESION 2 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 2.75 MM X 38 MM OVERLAPPED WITH 3.50 MM X 32 MM SYNERGY CHINA REGISTRY STENT SYSTEMS. FOLLOWING POST DILATION, THE RESIDUAL STENOSIS WAS 0%. FIVE DAYS LATER, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2021, THE SUBJECT DIED. THE PRIMARY CAUSE OF DEATH IS UNEXPLAINED DEATH AND IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED.

    Description of Event or Problem · 0

    SAME CASE AS PR ID#: (B)(4). SYNERGY CHINA REGISTRY. IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6 2020, THE SUBJECT PRESENTED WITH SYMPTOMS OF SILENT ISCHEMIA AND STABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION 1 WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH 99% STENOSIS AND WAS 21 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.7 MM. THE TARGET LESION 1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.00 MM X 24 MM SYNERGY CHINA REGISTRY STENT SYSTEM. FOLLOWING POST DILATION, THE RESIDUAL STENOSIS WAS 0%. THE TARGET LESION 2 WAS LOCATED IN PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY EXTENDING UP TO MID LAD WITH 99% STENOSIS AND WAS 65 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM. THE TARGET LESION 2 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 2.75 MM X 38 MM OVERLAPPED WITH 3.50 MM X 32 MM SYNERGY CHINA REGISTRY STENT SYSTEMS. FOLLOWING POST DILATION, THE RESIDUAL STENOSIS WAS 0%. FIVE DAYS LATER, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2021, THE SUBJECT DIED. THE PRIMARY CAUSE OF DEATH IS UNEXPLAINED DEATH AND IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED. IT WAS FURTHER REPORTED THAT THE PHYSICIAN DID NOT CONSIDER THE DEATH RELATED TO THE DEVICE AND THAT NO ACTION WAS TAKEN TO TREAT THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1810190 SYNERGY CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC CORPORATION 10623 0025142053

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Death