BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX

    MDR report key: 7120362 · Received December 15, 2017

    Report

    Report Number
    9612164-2017-01954
    Event Type
    Injury
    Date Received
    December 15, 2017
    Date of Event
    June 7, 2017
    Report Date
    December 15, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT -DATE OF PUBLICATION WILEY INTERVENTIONAL CARDIOLOGY "COMPARISON BETWEEN IMPORTED VERSUS DOMESTIC DRUG-ELUTING STENTS IN CHINA: A LARGE SINGLE-CENTER DATA" DOI: 10.1111/JOIC.12402 MEDTRONIC, INC. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    FROM JANUARY TO DECEMBER 2013 PATIENTS 9011 WERE ANALYSED IN THIS STUDY FOR COMPARISON OF IMPORTED DRUG ELUTING STENTS(DES) VERSUS DOMESTIC DRUG-ELUTING STENTS IN (B)(4). INCLUDED IN THE DES THAT WERE IMPLANTED WERE ENDEAVOR AND ENDEAVOR RESOLUTE DRUG ELUTING STENTS. CLINICAL OUTCOME OF 2-YEAR FOLLOW-UP REPORTED ARE: DEATH (ALL CAUSE), CARDIAC DEATH, MYOCARIDAL INFARCTION, TARGET VESSEL MYOCARDIAL INFARCTION, REVASCULARIZATION OF THE TARGET LESION AND TARGET VESSEL, STROKE AND STENT THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902437 ENDEAVOR RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R