BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 2991965 · Received March 7, 2013

    Report

    Report Number
    9612164-2013-00255
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    December 27, 2011
    Report Date
    March 4, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (GI BLEED). (B)(4).

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE THERE WAS ONE ENDEAVOR SPRINT RX DRUG ELUTING STENT IMPLANTED IN THE RCA. IT IS REPORTED THAT APPROXIMATELY 5 DAYS POST INDEX PROCEDURE THE PATIENT SUFFERED A GASTROINTESTINAL (GI) BLEED. THE PATIENT WAS HOSPITALIZED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    THE PATIENT HAD DAPT INTERUPTED FOR 2 WEEKS FOLLOWING THE PREVIOUSLY REPORTED GI BLEED WHICH OCCURED 5 DAYS POST INDEX PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96816 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0005601241

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Hospitalization| R ASPIRIN AND CLOPIDOGREL