BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX CORONARY STENT SYSTEM

    MDR report key: 2223884 · Received August 18, 2011

    Report

    Report Number
    9612164-2011-00968
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    September 9, 2008
    Report Date
    July 22, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: DISSECTION.

    Description of Event or Problem · 1

    AN ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENT AND TWO OTHER BRAND STENTS WERE IMPLANTED IN THE RCA DURING THE INDEX PROCEDURE. IT IS REPORTED THAT THERE WAS A DISSECTION OBSERVED AFTER POST DILATION OF THE ENDEAVOR STENT AND THE TWO OTHER BRAND STENTS WERE IMPLANTED TO TREAT THE DISSECTION. IT IS REPORTED THAT THE PATIENT RECOVERED WITH TREATMENT. IN THE INVESTIGATORS OPINION, THE DISSECTION WAS NOT RELATED TO THE STUDY STENT BUT WAS DEFINITELY RELATED TO THE STUDY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0000505808

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention