BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 8230564 · Received January 9, 2019

    Report

    Report Number
    9612164-2019-00124
    Event Type
    Injury
    Date Received
    January 9, 2019
    Date of Event
    November 7, 2018
    Report Date
    January 9, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P160043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF PUBLICATION CULOTTE VERSUS THE NOVEL NANO-CRUSH TECHNIQUE FOR UNPROTECTED COMPLEX BIFURCATION LEFT MAIN STENTING: DIFFERENCE IN PROCEDURAL TIME, CONTRAST VOLUME AND X-RAY EXPOSURE AND 3-YEARS OUTCOMES. HTTPS://DOI.ORG/10.1007/S10554-018-1497-8 . IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THIS STUDY ANALYSED THE PROCEDURAL AND MEDICAL RECORDS OF PATIENTS ADMITTED FROM 1 JANUARY 2014 TO 1 NOVEMBER 2017 WHO HAD COMPLEX LM BIFURCATION DISEASE AND CONTRAINDICATIONS AND/ OR REFUSAL TO SURGERY AND RECEIVED DOUBLE STENTING USING A VERY MINIMAL CRUSH TECHNIQUE (NANO-CRUSH) OR CULOTTE STENTING AT THE OPERATORS¿ DISCRETION, USING NON-MEDTRONIC OR RESOLUTE ONYX DRUG ELUTING STENTS. 65 PATIENTS OUT OF 224 PATIENTS SUBMITTED TO LM STENTING RECEIVED LM DOUBLE STENTING FULFILLING THE INCLUSION CRITERIA: 32 PATIENTS RECEIVED NANO-CRUSH WHILE 33 PATIENTS RECEIVED CULOTTE TECHNIQUE. STENT EMBOLIZATION OCCURRED WHILE CROSSING CALCIFIED AND TORTUOUS LCX ARTERY OSTIUM IN THREE CASES AND CROSSING DISTAL CALCIFIED LM IN TWO CASES: ALL WERE SNARED SUCCESSFULLY. POST-OPERATIVE SUCCESS WAS ACHIEVED IN 100% OF CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25208 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention