BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3921599 · Received July 9, 2014

    Report

    Report Number
    9612164-2014-00751
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    August 2, 2010
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE, TWO ENDEAVOR SPRINT DRUG ELUTING STENTS WERE USED TO TREAT A LESION IN THE LAD. STENT IMPLANTATION WAS SUCCESSFUL; HOWEVER, AN ANGIOGRAPHIC COMPLICATION OF PLAQUE PROLAPSE OCCURRED DURING THE INDEX PROCEDURE WHICH WAS RESOLVED WITH BALLOON INFLATION. THE EVENT WAS NOT ASSESSED FOR RELATEDNESS TO THE STUDY DEVICE. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400418 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0000903354

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention