BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 2792570 · Received October 16, 2012

    Report

    Report Number
    9612164-2012-01526
    Event Type
    Injury
    Date Received
    October 16, 2012
    Date of Event
    October 23, 2011
    Report Date
    March 6, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE, THE PATIENT HAD ONE ENDEAVOR SPRINT DRUG-ELUTING STENTS SUCCESSFULLY DEPLOYED FROM THE NATIVE OM TO THE SAPHENOUS VEIN GRAPH AND ONE ENDEAVOR SPRINT DRUG ELUTING STENT SUCCESSFULLY DEPLOYED IN THE OSTIUM OF THE SAPHENOUS. APPROXIMATELY 20 MONTHS POST INDEX PROCEDURE, PATIENT WAS ADMITTED WITH GI BLEED AND BLOODY STOOL, PATIENT WAS TAKEN OF PLAVIX, ASPIRIN AND GIVEN A BLOOD TRANSFUSION. INVESTIGATOR INDICATED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE.

    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 Hospitalization CLOPIDOGREL AND ASPIRIN