BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 7964620 · Received October 15, 2018

    Report

    Report Number
    9612164-2018-02738
    Event Type
    Injury
    Date Received
    October 15, 2018
    Date of Event
    April 26, 2018
    Report Date
    October 15, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF PUBLICATION PACLITAXEL-COATED BALLOON TREATMENT FOR FUNCTIONALLY NONSIGNIFICANT RESIDUAL CORONARY LESIONS AFTER BALLOON ANGIOPLASTY. AVAILABLE : HTTPS://DOI.ORG/10.1007/S10554-018-1351-Z. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL THAT RESOLUTE INTEGRITY WERE INCLUDED IN A STUDY COMPARING THE EFFICACY OF PCB TREATMENT WITH STENT IMPLANT IN NEW LESIONS FOLLOWING SUCCESSFUL POBA. INCLUSION CRITERIA WERE THE PRESENCE OF A SINGLE NEW CORONARY LESION WITH A REFERENCE DIAMETER BETWEEN 2.5 AND 3.5MM, A LESION LENGTH <(><<)>_ 24MM AND TIMI FLOW 3 FOLLOWING POBA. LESIONS TREATED INCLUDED LAD, LCX AND RCA. ADVERSE EVENTS REPORTED INCLUDE MYOCARDIAL INFRACTION, IN STENT -STENOSIS AND TVR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806912 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization