BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 6710090 · Received July 13, 2017

    Report

    Report Number
    9612164-2017-00883
    Event Type
    Injury
    Date Received
    July 13, 2017
    Date of Event
    January 1, 2017
    Report Date
    June 15, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P160043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT DATE IS THE DATE THE ARTICLE WAS PUBLISHED. THE CINE IMAGES INCLUDED IN THE RETURNED JOURNAL ARTICLE SHOW THE TOTAL OCCLUSION OF THE RCA .THE 3.0 X 38MM RESOLUTE ONYX STENT IMPLANTED IN THE RCA. THE FINAL IMAGE SHOWS AN EXCELLENT END RESULT POST STENT IMPLANTATION. LITERATURE ARTICLE NAME: ELECTRICAL TSUNAMI THE NIGHTMARES OF CORONARY RE-PERFUSION DURING 1RY PCI JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOL 69, NO. 16.

    Description of Event or Problem · 1

    CATHETERIZATION SHOWED THAT THE RCA WAS TOTALLY OCCLUDED. THE PHYSICIAN DIRECT STENTED THE LESION WITH A RESOLUTE ONYX DRUG ELUTING. THE STENT WAS DEPLOYED AT 16ATMS. AFTER THE STENT WAS DEPLOYED THE PATIENT BECAME DISTRESSED, AGITATED WITH NAUSEA, VOMITING, SEVERE CHEST PAIN, DEVELOPED JUNCTIONAL RHYTHM THEN BECAME HYPOTENSIVE. THE PATIENT WAS TREATED WITH MEDICATION AND CPR AND RECOVERED. THE PATIENT WENT HOME 3 DAYS AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491800 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention