BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY¿

    MDR report key: 7069067 · Received November 29, 2017

    Report

    Report Number
    2134265-2017-11883
    Event Type
    Injury
    Date Received
    November 29, 2017
    Date of Event
    September 15, 2017
    Report Date
    November 7, 2017
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 FURTHER REPORTED THAT ON (B)(6) 2017, THE PATIENT WAS HOSPITALIZED IN VIEW OF UNSATISFACTORY LOW LOW-DENSITY LIPOPROTEIN (LDL) DUE TO STATIN INTOLERANCE AND RESTUDY OF CORONARY ARTERY DISEASE. IT WAS INITIALLY REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR PLANNED PERCUTANEOUS CORONARY INTERVENTION FOR TREATMENT IF IN STENT RESTENOSIS IN (B)(6) 2017 AND THE CORRECT DATE IS (B)(6) 2017.

    Description of Event or Problem · 1

    (B)(6) STUDY IT WAS REPORTED THAT IN-STENT RESTENOSIS (ISR) OCCURRED. IN (B)(6) 2016, A 3.0 X 24MM SYNERGY STENT WAS DEPLOYED TO TREAT A TARGET LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. IN (B)(6) 2017, THE PATIENT PRESENTED WITH CONGESTIVE HEART FAILURE AND WAS REFERRED FOR CARDIAC CATHETERIZATION. CORONARY ANGIOGRAPHY WAS PERFORMED ON THE SAME DAY REVEALING 90% ISR OF THE 3.00X24MM SYNERGY STENT IN THE PROXIMAL LAD. FOUR DAYS LATER, TREATMENT WAS PERFORMED WITH PRE-DILATATION AND PLACEMENT OF 3.5X12MM NON-BSC STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0% WITH TIMI FLOW 3. TREATMENT WITH LOW DOSE MEVALOTIN WAS RECOMMENDED. IN (B)(6) 2017, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848683 SYNERGY¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493926224300

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention