BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY¿

    MDR report key: 6033080 · Received October 17, 2016

    Report

    Report Number
    2134265-2016-09148
    Event Type
    Injury
    Date Received
    October 17, 2016
    Date of Event
    September 20, 2016
    Report Date
    September 20, 2016
    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

    DEVICE IS A COMBINATION PRODUCT. AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN-STENT RESTENOSIS (ISR) OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL TO MID RIGHT CORONARY ARTERY (RCA). A SYNERGY STENT WAS THEN SUCCESSFULLY IMPLANTED. HOWEVER, ISR WAS NOTED. A NON-BSC INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION. A 10/3.00 FLEXTOME¿ CUTTING BALLOON¿ WAS ADVANCED TO PREDILATE THE LESION BUT FAILED TO CROSS THE LESION. AN NC EMERGE BALLOON WAS USED AND PREDILATED THE LESION. IVUS WAS THEN PERFORMED. A GUIDEZILLA GUIDE EXTENSION CATHETER AND A DRUG-COATING BALLOON WAS SELECTED AS TREATMENT OF THE MID RCA. A 3.50 X 8 SYNERGY¿ STENT WAS THEN ADVANCED TO TREAT THE OSTIAL PROXIMAL RCA. HOWEVER, STRONG RESISTANCE WAS ENCOUNTERED AND THE DEVICE FAILED TO CROSS THE LESION. AN NC EMERGE BALLOON PREDILATED THE OSTIAL PROXIMAL RCA AND THE 3.50 X 8 SYNERGY¿ STENT WAS RE-INTRODUCED AND SUCCESSFULLY DEPLOYED. IVUS WAS PERFORMED WITH NO ISSUES NOTED AND THE PROCEDURE WAS COMPLETED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685183 SYNERGY¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY UNK744

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention