BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT OTW CORONARY STENT SYSTEM

    MDR report key: 1963258 · Received January 13, 2011

    Report

    Report Number
    2953200-2011-00097
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 16, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    TWO ENDEAVOR SPRINT OTW DRUG-ELUTING STENT WAS IMPLANTED OVERLAPPING IN THE PROX LAD DURING THE INDEX PROCEDURE. PT HAD DISSECTION AFTER THE FIRST STENT WAS PLACED AND THE SECOND STENT WAS PLACED TO TREAT THE DISSECTION. PT RECOVERED WITH TREATMENT AND WAS DISCHARGED THE SAME DAY AS THE INDEX PROCEDURE. IN THE OPINION OF THE INVESTIGATOR, THE EVENT WAS MILD IN INTENSITY, DEFINITELY RELATED TO THE STUDY DEVICE AND STUDY PROCEDURE AND NOT RELATED TO THE STUDY DRUG.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention AND ASPIRIN AT THE TIME OF EVENT.| PT WAS TAKING CLOPIDORGEL