BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 9995467 · Received April 24, 2020

    Report

    Report Number
    9612164-2020-01681
    Event Type
    Injury
    Date Received
    April 24, 2020
    Date of Event
    November 19, 2019
    Report Date
    April 24, 2020
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P160043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE: AVERAGE AGE. MAJORITY GENDER. DATE OF PUBLICATION JOURNAL ARTICLE TITLE: CORONARY PROTECTION TO PREVENT CORONARY OBSTRUCTION DURING TAVR LITERATURE REFERENCE: DOI.ORG/10.1016/J.JCIN.2019.11.024. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE AIM OF THIS STUDY WAS TO INVESTIGATE THE SAFETY AND EFFICACY OF CORONARY PROTECTION BY PREVENTIVE CORONARY WIRING AND STENTING ACROSS THE CORONARY OSTIA IN PATIENTS AT HIGH RISK FOR CORONARY OBSTRUCTION AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). THIS MULTICENTER, INTERNATIONAL, RETROSPECTIVE STUDY ENROLLED 236 PATIENTS UNDERGOING CP WITH PREEMPTIVE WIRING OF THE CORONARY ARTERIES BETWEEN APRIL 2011 AND FEBRUARY 2019. AMONG 236 PATIENTS UNDERGOING CORONARY PROTECTION WITH PREVENTIVE CORONARY WIRING, 143 HAD EVENTUALLY STENTS IMPLANTED ACROSS THE CORONARY OSTIA AFTER VALVE DEPLOYMENT. RESOLUTE ONYX WERE IMPLANTED IN 23 PATIENTS PARTICIPATING IN THE STUDY. AT 3-YEAR FOLLOW-UP, RATES OF CARDIAC DEATH WERE 7.8% IN PATIENTS RECEIVING STENTS AND 15.7% IN THOSE NOT RECEIVING STENTS. 3-YEAR CLINICAL OUTCOMES OF PATIENTS UNDERGOING CP WITH STENTING ACROSS THE CORONARY OSTIA INCLUDED CARDIAC MORTALITY, MI, STROKE AS WELL AS TWO OCCURRENCES OF STENT THROMBOSIS WHICH WERE FATAL IN BOTH CASES. IT WAS NOTED BOTH CASES OF STENT THROMBOSIS OCCURRED IN PATIENTS RECEIVING SELF-EXPANDING VALVES IMPLANTED IN VALVE-IN-VALVE PROCEDURE FOR FAILED NON-MEDTRONIC BIOPROSTHETIC VALVES. IT WAS STATED THAT THERE WERE 4 CASES OF SUDDEN DEATH, 2 IN PATIENTS RECEIVING STENTS AT 365 AND 703 DAYS AFTER TAVR. IT WAS NOTED THAT THERE WERE 13 DEATHS, 6 CARDIAC DEATHS, 8 MIS, AND 5 STROKES AMONG THE 143 PATIENTS UNDERGOING CORONARY PROTECTION WITH STENT IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460064 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention