BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3379033 · Received October 1, 2013

    Report

    Report Number
    9612164-2013-00951
    Event Type
    Death
    Date Received
    October 1, 2013
    Date of Event
    January 1, 2013
    Report Date
    September 4, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). USEFULNESS OF INTRAVASCULAR ULTRASOUND TO PREDICT OUTCOMES AMERICAN JOURNAL OF CARDIOLOGY ALERT, 2013, VOL. 112, ISSUE 5 (WWW.AJCONLINE.ORG) 2013 0002-9149/13/$.

    Description of Event or Problem · 1

    A STUDY WAS CARRIED OUT TO SEE THE ¿USEFULNESS OF INTRAVASCULAR ULTRASOUND TO PREDICT OUTCOMES IN SHORT-LENGTH LESIONS TREATED WITH DRUG-ELUTING STENTS¿. A TOTAL OF 662 PATIENT WITH IVUS GUIDANCE AND 912 PATIENTS WITH ANGIOGRAPHY GUIDANCE WHO UNDERWENT DES IMPLANTATION WERE INVOLVED IN THE STUDY. PATIENT OUTCOMES INCLUDED DEATH, MI, STENT THROMBOSIS AND REVASCULARIZATIONS. THE STUDY CONCLUDED THAT THERE WERE NO STATISTICALLY SIGNIFICANT DIFFERENCES FOUND BETWEEN THE 2 GROUPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493914 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Death