BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 4133930 · Received October 2, 2014

    Report

    Report Number
    9612164-2014-01256
    Event Type
    Injury
    Date Received
    October 2, 2014
    Date of Event
    January 18, 2014
    Report Date
    September 29, 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). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (STROKE/TRANSIENT ISCHEMIC ATTACK).

    Description of Event or Problem · 1

    ONE ENDEAVOR SPRINT DRUG ELUTING STENT WAS IMPLANTED IN THE RCA DURING INDEX PROCEDURE. APPROXIMATELY 1 MONTH LATER DURING A STAGED PROCEDURE, ONE ENDEAVOR SPRINT DRUG ELUTING STENT WAS IMPLANTED IN THE LAD. APPROXIMATELY 27.5 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED A STROKE. THE PATIENT WAS HOSPITALIZED. INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE. THE OUTCOME OF THE EVENT IS REPORTED AS DISABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614414 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0001148471

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Hospitalization