BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX

    MDR report key: 7098482 · Received December 7, 2017

    Report

    Report Number
    9612164-2017-01829
    Event Type
    Injury
    Date Received
    December 7, 2017
    Date of Event
    June 16, 2016
    Report Date
    December 8, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL NAME: CARDIOVASC INTERV AND THER TITLE OF ARTICLE: COMPARISON OF MID-TERM OUTCOMES BETWEEN PATIENTS WITH AND WITHOUT ATRIAL FIBRILLATION UNDERGOING CORONARY STENTING IN THE SECOND-GENERATION DRUG-ELUTING STENT ERA:FROM THE SHINANO REGISTRY LIT REFERENCE: DOI 10.1007/S12928-016-0406-0 RECEIVED: 18 JANUARY 2016/ACCEPTED: 9 JUNE 2016/PUBLISHED 16 JUNE 2016.

    Description of Event or Problem · 1

    RESOLUTE AND ENDEAVOR DRUG ELUTING STENT DEVICES WERE USED TO TREAT IN-STENT RESTENOSIS, CALCIFIED LESIONS, OSTIAL LESIONS, BIFURICATED LESIONS, LEFT MAIN TRUNK LESIONS AND OCCLUDED LESIONS A STUDY WAS CARRIED OUT WHICH EVALUATED THE 1 YEAR OUTCOMES OF AF PATIENTS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION (PCI) SECOND GENERATION DRUG ELUTING STENTS (DES). IT IS REPORTED THAT ADVERSE EVENTS INCLUDING CARDIAC AND NON-CARDIAC PATIENT DEATH, MI, STROKE AND MAJOR BLEEDING. IT IS ALSO REPORTED THAT POSITIONING DIFFICULTIES OCCURRED IN 6 CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874118 ENDEAVOR RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR