BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2051134 · Received April 5, 2011

    Report

    Report Number
    9612164-2011-00154
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    February 21, 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
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION, RESULTS: MI, TVR.

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE, THE PATIENT HAD ONE ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT IMPLANTED TO THE PROXIMAL LAD. FIVE DAYS POST PROCEDURE, THE PATIENT IS REPORTED TO HAVE SUFFERED AN MI. THE LOCATION OF THE INFARCTION WAS NON-DETERMINABLE. THE PATIENT RECEIVED NITROGLYCERIN, HOWEVER, THE CHEST PAIN PERSISTED AND A TARGET VESSEL REVASCULARIZATION WAS PERFORMED. THE PATIENT RECEIVED TWO ADDITIONAL STENTS, ONE TO THE 1ST DIAGONAL AND ONE TO THE MID LAD. THE INVESTIGATOR ASSESSED THAT THERE WAS NO RELATIONSHIP BETWEEN THE EVENT AND THE STUDY DEVICE OR STUDY DRUG. THE PATIENT RECOVERED WITH TREATMENT AND NO OTHER CLINICAL SEQUELAE WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention ASPIRIN| PRASUGREL