BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3911419 · Received July 3, 2014

    Report

    Report Number
    9612164-2014-00701
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    April 27, 2014
    Report Date
    July 15, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    TWO ENDEAVOR SPRINT DRUG-ELUTING STENTS WERE IMPLANTED IN THE LAD. APPROXIMATELY 35 MONTHS POST PROCEDURE, THE PATIENT SUFFERED A GI BLEED. PATIENT WAS TREATED WITH MEDICATION. INVESTIGATOR ASSESSED THAT THE REPORTED EVENT WAS NOT RELATED TO THE STUDY DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECOVERED WITH TREATMENT FOLLOWING THE PREVIOUSLY REPORTED GI BLEED WHICH OCCURRED APPROX APPROXIMATELY 58 MONTHS POST INDEX PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390051 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Hospitalization| R CLOPIDOGREL AND ASPIRIN.