BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR OTW

    MDR report key: 9189892 · Received October 15, 2019

    Report

    Report Number
    9612164-2019-04354
    Event Type
    Injury
    Date Received
    October 15, 2019
    Date of Event
    September 2, 2019
    Report Date
    October 15, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL TITLE: CLINICAL OUTCOMES OF CORONARY ARTERY BIFURCATION DISEASE PATIENTS UNDERWENT CULOTTE TWO-STENT TECHNIQUE: A SINGLE CENTER EXPERIENCE. DATE OF EVENT: DATE OF PUBLICATION. DOI.ORG/10.1186/S12872-019-1192-2. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT A SELECTION OF PATIENTS IN A STUDY RECEIVED RESOLUTE INTEGRITY, ENDEAVOUR RESOLUTE AND ENDEAVOUR DRUG ELUTING STENTS. 238 CABD PATIENTS WERE ANALYZED IN THIS STUDY. MAINLY LEFT MAIN AND LEFT ANTERIOR DESCENDING ARTERY'S WERE TREATED BY CULOTTE STENTING. ADVERSE EVENTS EXPERIENCED INCLUDED MYOCARDIAL INFARCTION, CARDIAC AND NON-CARDIAC DEATH, TARGET VESSEL AND TARGET LESION REVASCULARIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989465 ENDEAVOR OTW STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention