BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3921884 · Received July 9, 2014

    Report

    Report Number
    9612164-2014-00753
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    March 14, 2011
    Report Date
    June 18, 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

    (B)(4).

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE, TWO ENDEAVOR SPRINT DRUG ELUTING STENTS WERE IMPLANTED; ONE IN THE 1ST OM AND ONE IN THE 1ST DIAGONAL. APPROXIMATELY ONE MONTH POST INDEX PROCEDURE DURING A STAGED PROCEDURE, TWO ENDEAVOR SPRINT DRUG ELUTING STENTS WERE IMPLANTED IN THE RCA. THE STENTS WERE SUCCESSFULLY IMPLANTED; HOWEVER, AN ANGIOGRAPHIC COMPLICATION OF PERFORATION OCCURRED DURING THE STAGED PROCEDURE. THE PATIENT WAS DISCHARGED 4 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401313 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0001127231

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR