BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1905383 · Received November 18, 2010

    Report

    Report Number
    2953200-2010-02260
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 21, 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
    MD, 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 RCA. A SECOND ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENT WAS IMPLANTED IN THE MID RCA TO TREAT THE TARGET LESION. THERE WAS A DISTAL DISSECTION NOTED AFTER THIS STENT WAS IMPLANTED AND A THIRD ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENT WAS IMPLANTED TO TREAT THE DISSECTION. ANOTHER DISSECTION WAS PRESENT DISTAL TO THIS STENT AND A FOURTH STENT WAS IMPLANTED TO TREAT THIS DISSECTION. PT REMAINED STABLE THROUGHOUT PROCEDURE. (MFG#2953200-2010-02261).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention