BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 7032048 · Received November 15, 2017

    Report

    Report Number
    9612164-2017-01611
    Event Type
    Injury
    Date Received
    November 15, 2017
    Date of Event
    March 24, 2016
    Report Date
    November 15, 2017
    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

    AUTHORS: KANG, SI-HYUCK; CHAE, IN-HO; PARK, JIN-JOO; LEE, HAK SEUNG; KANG, DO-YOON; HWANG, SEUNG-SIK; YOUN, TAE-JIN; KIM, HYO-SOO; NLM JOURNAL NAME: JACC. CARDIOVASCULAR INTERVENTIONS YEAR: 2016 ISSUE: 12 TITLE: STENT THROMBOSIS WITH DRUG-ELUTING STENTS AND BIORESORBABLE SCAFFOLDS: EVIDENCE FROM A NETWORK META-ANALYSIS OF 147 TRIALS REF: HTTP://DX.DOI.ORG/10.1016/J.JCIN.2016.03.038.

    Description of Event or Problem · 1

    IN THE STUDY, THE SAFETY OF VARIOUS CONTEMPORARY DES IN TERMS OF THE RISK OF STENT THROMBOSIS (ST) OR DEVICE THROMBOSIS WAS COMPARED. A TOTAL OF 147 TRIALS INCLUDING 126,526 PATIENTS WERE ANALYSED IN THE STUDY. ENDEAVOR ZOTAROLIMUS-ELUTING STENTS AND RESOLUTE ZOTAROLIMUS-ELUTING STENTS WERE USED. PATIENT OUTCOMES INCLUDE DEATH, STENT THROMBOSIS, MYOCARDIAL INFARCTION, TARGET LESION REVASCULARISATION AND TARGET VESSEL REVASCULARISATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814263 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening