BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX

    MDR report key: 7440694 · Received April 18, 2018

    Report

    Report Number
    9612164-2018-00828
    Event Type
    Injury
    Date Received
    April 18, 2018
    Date of Event
    November 17, 2017
    Report Date
    April 18, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: DOMESTIC EVENT - FOREIGN EVENT TICKED IN ERROR IN INITIAL REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE: EFFECT OF INCREASING STENT LENGTH ON 3-YEAR CLINICAL OUTCOMES IN WOMEN UNDERGOING PERCUTANEOUS CORONARY INTERVENTION WITH NEW-GENERATION DRUG-ELUTING STENTS PATIENT-LEVEL POOLED ANALYSIS OF RANDOMIZED TRIALS FROM THE WIN-DES INITIATIVE AUTHORS: JAYA CHANDRASEKHAR, MBBS, MS, USMAN BABER, MD, MS, SAMANTHA SARTORI, PHD, GIULIO G. STEFANINI, MD, PHD, MICHELE SARIN, MS, BIRGIT VOGEL, MD, ET AL. LITERATURE REFERENCE: H T T P S: / / D O I. O R G / 1 0. 1 0 1 6 / J. J C I N. 2 0 1 7. 1 1. 0 2 0 JOURNAL: J A C C: C A R D I OV A S C U L A R I N T E R V E N T IO N S ISSUE #: 1 YEAR: 2 0 1 8 . IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING PROCEDURES, ENDEAVOR AND RESOLUTE INTEGRITY DRUG ELUTING STENTS WERE IMPLANTED. THE FOLLOWING WERE REPORTED FOR 3-YEAR CLINICAL OUTCOMES - DEATH, MYOCARDIAL INFARCTION, STENT THROMBOSIS AND TLR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283860 ENDEAVOR RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other