BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY¿

    MDR report key: 3015292 · Received March 21, 2013

    Report

    Report Number
    2134265-2013-01842
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 22, 2013
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF 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 DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) STENT DAMAGE POST DEPLOYMENT OCCURRED. THE ACCESS WAS OBTAINED VIA RADIAL ARTERY. A 6F SHEATH WAS INSERTED IN THE RIGHT RADIAL ARTERY. A 5F CORONARY CATHETER WAS THE INSERTED IN THE LEFT CORONARY ARTERY (LCA) AND IN THE RIGHT CORONARY ARTERY (RCA) TO PERFORM THE ANGIOGRAPHY. A 6F GUIDECATHETER WAS THEN INTRODUCED TO PERFORM THE PCI IN THE LCA. A 0.014 GUIDEWIRE WAS PLACED IN THE LAD. A 3.5X15MM MAVERICK BALLOON WAS USED AT 16ATM FOR 23 SEC TO PREDILATE THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). A SYNERGY STENT 4.0X20MM WAS THEN DEPLOYED AT 16 ATM FOR 30 SEC, AND POSTDILATED WITH THE DELIVERY SYSTEM BALLOON AT 22ATM FOR 20 SEC. A FURTHER POSTDILATION WAS PERFORMED USING A 5.0X15MM QUANTUM APEX BALLOON AT 18ATM FOR 12 SEC, 20ATM FOR 11SEC AND 20ATM FOR 19 SEC. A 4.0X12MM SYNERGY STENT WAS THEN INTRODUCED, OVERLAPPING THE 4.0X20MM STENT. AFTER INFLATION AT 20ATM FOR 23SEC AND AT 26ATM FOR 28 SEC, IT WAS NOTICED THAT THERE WAS A GAP BETWEEN BOTH STENTS AND THE PHYSICIAN THINKS THE STENT COULD HAVE SHORTENED UPON POST DILATION. THE PATIENT REMAINED STABLE AND NO FURTHER COMPLICATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118273 SYNERGY¿ CORONARY DRUG-ELUTING STENT NIQ H7493919812400 15638837

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR BSC QUANTUM APEX BALLOON 5.0X15MM| BSC MAVERICK BALLOON 3.5X15MM| SHEATH 6F CORDIAS AVANTI + 11CM| BSC SYNERGY STEN 4.0X20MM| GUIDECATHETER .014 MEDTRONIC EBU 3.5| 5F TERUMO TIG CORONARY CATHETER