BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY¿

    MDR report key: 7053354 · Received November 22, 2017

    Report

    Report Number
    2134265-2017-11618
    Event Type
    Injury
    Date Received
    November 22, 2017
    Date of Event
    September 15, 2017
    Report Date
    November 2, 2017
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE INVESTIGATION CONCLUSION IS ANTICIPATED PROCEDURAL COMPLICATION AS THE EVENT IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE DIRECTIONS FOR USE, AND/OR DEVICE LABELING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN-STENT RESTENOSIS (ISR) OCCURRED. IN (B)(6) 2016, THE PATIENT WAS HOSPITALIZED FOR CORONARY ANGIOGRAPHY (CAG) EXAMINATION. ON THE FOLLOWING DAY, CAG EXAMINATION WAS PERFORMED AND STENOSIS WAS OBSERVED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THREE WEEKS AFTER CAG EXAMINATION, THE PATIENT WAS HOSPITALIZED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE IN THE PROXIMAL LAD. THE NEXT DAY, INDEX PROCEDURE WAS PERFORMED. A 3.00 X 24 SYNERGY¿ DRUG-ELUTING STENT WAS PLACED IN THE 90% STENOSED PROXIMAL LAD RESULTING IN 0% STENOSIS. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED SINCE THE PROGRESS WAS GOOD. IN (B)(6) 2017, WHEN A FOLLOW-UP CAG EXAMINATION WAS PERFORMED, 75-90% STENOSIS WAS OBSERVED IN THE PROXIMAL LAD. IN (B)(6) 2017, THE PATIENT WAS HOSPITALIZED FOR PCI IN THE PROXIMAL LAD. THE FOLLOWING DAY, PCI PROCEDURE WAS PERFORMED. A 3.5×12 MM NON BSC STENT WAS IMPLANTED IN THE LEFT MAIN TRUNK TO THE PROXIMAL LAD RESULTING IN 0% RESIDUAL STENOSIS. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED SINCE THE PROGRESS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832870 SYNERGY¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493926224300

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R