BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 8212456 · Received January 3, 2019

    Report

    Report Number
    9612164-2019-00032
    Event Type
    Injury
    Date Received
    January 3, 2019
    Date of Event
    March 3, 2018
    Report Date
    January 3, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LIT REF: HTTPS://DOI.ORG/10.1016/J.CARREV.2018.08.009. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THIS TRIAL COMPARED PACLITAXEL DCB (IN.PACT FALCON, MEDTRONIC INC.) VERSUS ZOTAROLIMUS DES (RESOLUTE INTEGRITY, MEDTRONIC INC.) IN PATIENTS WITH DE NOVO LESIONS IN SMALL VESSELS. THE PRIMARY ENDPOINT WAS THE COMPOSITE OF MAJOR ADVERSE CARDIAC EVENTS (MACE) INCLUDING CARDIAC DEATH, MYOCARDIAL INFARCTION, CORONARY ARTERY BYPASS GRAFTING, (CABG), AND CLINICALLY-DRIVEN TARGET VESSEL REVASCULARIZATION (TVR) OR TARGET LESION REVASCULARIZATION (TLR) AT 12 MONTHS. THE NUMBER OF PATIENTS INCLUDED WAS 94 (137 LESIONS), OF WHICH 49 (74 LESIONS) WERE RANDOMIZED TO DCB AND 45 (63 LESIONS) TO DES. THERE WAS NO DIFFERENCE IN THE SIZE OF THE TREATED VESSELS, THE TYPE OF LESIONS AND BALLOON PREDILATATION BETWEEN THE 2 GROUPS. 4 PATIENTS CROSSED OVER FROM THE DCB GROUP TO THE DES GROUP DUE TO LACK OF SUCCESS FROM THE DCB TREATMENT, REQUIRING BARE METAL STENT IMPLANTATION. THERE WERE 2 DISSECTIONS IN THE DES GROUP AND 7 DISSECTIONS IN THE DCB GROUP. AT 12 MONTHS, THERE WERE NO REPORTED DEATHS,MYOCARDIAL INFARCTIONS OR CABG IN BOTH GROUPS. CLINICALLY DRIVEN TVR WAS REPORTED IN 2 PATIENTS IN THE DCB GROUP AND CLINICALLY DRIVEN TLR WAS REPORTED IN 1 PATIENT IN THE DES GROUP. IN THE DES GROUP, 4 PATIENTS UNDERWENT REVASCULARIZATION IN ANOTHER VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4127 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention