BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3840186 · Received May 30, 2014

    Report

    Report Number
    9612164-2014-00547
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    April 4, 2013
    Report Date
    May 27, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE, ONE ENDEAVOR SPRINT DRUG-ELUTING STENT WAS IMPLANTED IN THE RIGHT POSTERIOR LATERAL ARTERY. APPROXIMATELY 20 MONTHS POST INDEX PROCEDURE, THE PATIENT WAS HOSPITALIZED DUE TO A GI BLEED (MELENA WITH FRESH BLOOD). CLIPPING WAS PERFORMED IN THE LARGE INTESTINE. INVESTIGATOR INDICATED THAT THE REPORTED EVENT WAS NOT RELATED TO THE STUDY DEVICE. APPROXIMATELY 34 MONTHS POST INDEX PROCEDURE PATIENT WAS HOSPITALIZED DUE TO A GI BLEED (MELENA WITH FRESH BLOOD). CLIPPING AND CF WAS PERFORMED IN THE LARGE INTESTINE. INVESTIGATOR INDICATED THAT THE REPORTED EVENT WAS NOT RELATED TO THE STUDY DEVICE. APPROXIMATELY 41.5 MONTHS, THE PATIENT WAS HOSPITALIZED DUE TO A BLEED IN THE LARGE INTESTINE. NO INTERVENTION WAS PERFORMED. INVESTIGATOR INDICATED THAT THE REPORTED EVENT WAS NOT RELATED TO THE STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318438 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention CLOPIDOGREL AND ASPIRIN.