BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 5924531 · Received September 2, 2016

    Report

    Report Number
    9612164-2016-00934
    Event Type
    Malfunction
    Date Received
    September 2, 2016
    Date of Event
    April 5, 2016
    Report Date
    August 7, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT IS DATE ARTICLE AVAILABLE ON LINE. JOURNAL ARTICLE TITLE: INTRACORONARY NITROGLYCERIN INJECTION THROUGH A MICROCATHETER FOR CORONARY NO-REFLOW FOLLOWING PERCUTANEOUS CORONARY INTERVENTION INTERNATIONAL JOURNAL OF CARDIOLOGY 214 (2016) 400¿402 0167-5273/© 2016 ELSEVIER IRELAND LTD. ALL RIGHTS RESERVED. CONTENTS LISTS AVAILABLE AT SCIENCEDIRECT INTERNATIONAL JOURNAL OF CARDIOLOGY JOURNAL HOMEPAGE: WWW.ELSEVIER .COM/LOCATE/IJCARD JOURNAL ARTICLE INTERNET ADDRESS: HTTP://DX. DOI.ORG/10.1016/J.IJCARD.2016.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PATIENT VISITED THE EMERGENCY DEPARTMENT FOR ONGOING CHEST PAIN FOR 2 HOURS. CAG WAS PERFORMED AND SHOWED TOTAL OCCLUSION OF THE MID-LEFT ANTERIOR DESCENDING ARTERY. AFTER BALLOON ANGIOPLASTY WITH A CONVENTIONAL COMPLIANT BALLOON, A RESOLUTE ONYX DRUG-ELUTING STENT WAS IMPLANTED. HOWEVER, POST-STENTING ANGIOGRAPHY REVEALED THE NO-REFLOW PHENOMENON. A MICROCATHETER WAS POSITIONED AT THE MID LAD AND ABCIXIMAB AND NITROGLYCERIN WERE INJECTED THROUGH THE GUIDING CATHETER BUT FAILED TO IMPROVE THE TIMI FLOW. THEN, THE PHYSICIAN INTRODUCED AND POSITIONED A MICROCATHETER (NON-MDT) INTO THE MIDDLE PART OF THE RCA AND INJECTED ABOUT 8 ML NITROGLYCERIN THROUGH THE MICROCATHETER AFTER REMOVING THE CORONARY GUIDEWIRE. THE FOLLOW-UP ANGIOGRAM REVEALED IMPROVED CORONARY FLOW AT THE PROXIMAL TO DISTAL CORONARY ARTERY. PHYSICIAN CARRIED OUT SEVERAL ADDITIONAL NITROGLYCERIN INJECTIONS THROUGH THE MICROCATHETER. THE FINAL ANGIOGRAM SHOWED MUCH IMPROVED CORONARY FLOW WITHOUT ANY COMPLICATIONS. THE PATIENT BECAME ASYMPTOMATIC AND WAS DISCHARGED WITHOUT COMPLICATIONS. PLEASE NOTE THAT THIS DEVICE RESOLUTE ONYX IS NOT MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES MARKETED DEVICE RESOLUTE INTEGRITY. THIS EVENT IS BEING REPORTED ONLY AS A MALFUNCTION BECAUSE OF THE SIMILAR DEVICE REQUIREMENT IN 803 WHICH IS LIMITED TO MALFUNCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577551 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention