BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1790020 · Received August 6, 2010

    Report

    Report Number
    2953200-2010-01496
    Event Type
    Injury
    Date Received
    August 6, 2010
    Date of Event
    June 15, 2010
    Report Date
    July 7, 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
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL RESULTS: DISSECTION.

    Description of Event or Problem · 1

    AN ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT WAS IMPLANTED IN THE PROXIMAL LAD TO TREAT THE TARGET LESION. ANOTHER ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT WAS IMPLANTED OVERLAPPING TO TREAT COMPLICATIONS OF A DISSECTION AFTER THE INITIAL STENT IMPLANTATION. PATIENT WAS DISCHARGED 1 DAY AFTER PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention