BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 2792468 · Received October 16, 2012

    Report

    Report Number
    9612164-2012-01525
    Event Type
    Injury
    Date Received
    October 16, 2012
    Date of Event
    October 2, 2012
    Report Date
    April 11, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: INHERENT RISK OF PROCEDURE -HAEMORRHAGE. (B)(4).

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE, THE PATIENT HAD ONE ENDEAVOR SPRINT DRUG-ELUTING STENT IMPLANTED IN THE 1ST DIAGONAL. APPROXIMATELY 20 MONTHS POST INDEX PROCEDURE, THE PATIENT SUFFERED A GI BLEED. PATIENT UNDERWENT AN ENDOSCOPY. INVESTIGATOR REPORTED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE. THE PATIENT RECOVERED.

    Description of Event or Problem · 1

    THE PATIENT HAD A BLOOD TRANSFUSION FOLLOWING THE PREVIOUSLY REPORTED GI BLEED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR Hospitalization| R XARELTO| ASPIRIN