BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT OTW

    MDR report key: 3052007 · Received April 11, 2013

    Report

    Report Number
    9612164-2013-00404
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    May 1, 2012
    Report Date
    April 2, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE, THE PATIENT HAD TWO ENDEAVOR SPRINT DRUG-ELUTING STENTS IMPLANTED, ONE IN THE LAD AND ONE IN THE CX. IT IS REPORTED THAT APPROXIMATELY 37 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED A GI BLEED. THE PATIENT HAD A BLOOD TRANSFUSION, AN ENDOSCOPY AND ESOPHAGOGASTRODUODENOSCOPY. THE INVESTIGATOR HAS ASSESSED THAT THE EVENT WAS NOT RELATED TO THE DEVICE. IT IS REPORTED THAT THE PATIENT RECOVERED WITH TREATMENT.

    Description of Event or Problem · 1

    THE PATIENT'S DUAL ANTIPLATELET THERAPY WAS DISCONTINUED FOLLOWING THE PREVIOUSLY REPORTED GI BLEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156537 ENDEAVOR SPRINT OTW STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Hospitalization ASPIRIN AND CLOPIDOGREL.