BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 6954262 · Received October 17, 2017

    Report

    Report Number
    9612164-2017-01470
    Event Type
    Injury
    Date Received
    October 17, 2017
    Date of Event
    December 29, 2016
    Report Date
    October 17, 2017
    Manufacturer
    MEDTRONIC
    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

    AUTHOR: JOO MYUNG LEE ,TAE-MIN RHEE, JOO-YONG HAHN, DOYEON HWANG, JONGHANNE PARK, JOURNAL: INTERNATIONAL JOURNAL OF CARDIOLOGY YEAR: 2016 ISSUE: 230 TITLE: COMPARISON OF OUTCOMES AFTER TREATMENT OF IN-STENT RESTENOSIS USING NEWER GENERATION DRUG-ELUTING STENTS VERSUS DRUG-ELUTING BALLOON: PATIENT-LEVEL POOLED ANALYSIS OF KOREAN MULTICENTER IN-STENT RESTENOSIS REGISTRY REF: HTTP://DX.DOI.ORG/10.1016/J.IJCARD.2016. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A GROUP OF PATIENTS WERE TREATED WITH RESOLUTE INTEGRITY AND ENDEAVOR RESOLUTE DRUG ELUTING STENTS TO TREAT IN STENT RESTENOSIS IN THE LEFT MAIN, LAD, LCX AND RCA ARTERIES. CLINICAL INDICATION OF PCI INCLUDE STABLE ANGINA, UNSTABLE ANGINA, NSTEMI, STEMI, ACUTE CORONARY SYNDROME AND SILENT ISCHEMIA. OUTCOMES IDENTIFIED DURING FOLLOW UPS INCLUDE DEATH, CARDIAC DEATH, TARGET LESION FAILURE, MI, TARGET VESSEL REVASCULARIZATION, TARGET LESION REVASCULARIZATION, CEREBROVASCULAR ACCIDENT, STENT THROMBOSIS AND PATIENT-ORIENTED COMPOSITE OUTCOMES (POCO).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735466 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention