BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2051105 · Received April 5, 2011

    Report

    Report Number
    9612164-2011-00155
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 9, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): (MI, REVASCULARIZATION).

    Description of Event or Problem · 1

    TWO ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENTS WERE IMPLANTED DURING THE INDEX PROCEDURE; ONE IN THE PROXIMAL LAD AND ONE IN A SEPARATE VESSEL. IT IS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH CHEST PAIN APPROXIMATELY 4 MONTHS POST INDEX PROCEDURE. PATIENT HAD CHEST X-RAY AND LABS PERFORMED. IT IS REPORTED THAT THE PATIENT WAS FOUND TO BE HAVING A MYOCARDIAL INFRACTION (MI). PATIENT HAD A HEART CATHETERIZATION AND WAS RESTENTED IN THE LAD. THE MI WAS CATEGORIZED AS AN ACUTE NON-STEMI. IT IS REPORTED THAT THE PATIENT RECOVERED WITH TREATMENT. INVESTIGATOR HAS INDICATED THAT THE EVENT HAD DEFINITE RELATIONSHIP TO THE STUDY DEVICE AND HAD REMOTE RELATIONSHIP TO THE STUDY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention