BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 8217360 · Received January 4, 2019

    Report

    Report Number
    9612164-2019-00054
    Event Type
    Death
    Date Received
    January 4, 2019
    Date of Event
    May 8, 2018
    Report Date
    January 4, 2019
    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

    LIT REF: HTTPS://DOI.ORG/10.4070/KCJ.2017.0387. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    FROM 2009 TO 2014, PATIENTS WITH STEMI AND MVD, WHO UNDERWENT PRIMARY PERCUTANEOUS CORONARY INTERVENTION (PCI) USING A 2ND GENERATION DES FOR CULPRIT LESIONS WERE ENROLLED. COMPLETE REVASCULARIZATION (CR) WAS DEFINED AS PCI FOR A NON-INFARCT-RELATED ARTERY DURING THE INDEX ADMISSION. ZOTAROLIMUS-DRUG-ELUTING STENTS WERE AMONG THE DEVICES USED. 286 (41%) UNDERWENT CULPRIT-ONLY PCI AND 419 (59%) UNDERWENT CR DURING THE INDEX ADMISSION. MAJOR ADVERSE CARDIOVASCULAR EVENT (MACE) WAS DEFINED AS CARDIOVASCULAR (CV) DEATH, NON-FATAL MYOCARDIAL INFARCTION, TARGET LESION REVASCULARIZATION, OR HEART FAILURE DURING THE FOLLOW-UP YEAR. ONE YEAR OUTCOMES INCLUDED DEATH, NON-FATAL MI, TLR AND HEART FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11740 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death| R