BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1901585 · Received November 12, 2010

    Report

    Report Number
    2953200-2010-02234
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    May 21, 2008
    Report Date
    October 13, 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
    NL
    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 LCX. A SECOND ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT WAS IMPLANTED IN THE DISTAL RCA TO TREAT THE TARGET LESION. TWO ADD'L ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENTS WERE IMPLANTED IN THE DISTAL RCA TO TREAT COMPLICATIONS OF A DISSECTION AFTER THE INITIAL STENT IMPLANTATION. AT 1 MONTH, 6 MONTH, 1 YR, 1.5 YR AND 2 YR F/U'S PT WAS ASYMPTOMATIC / FREE OF SYMPTOMS. IT IS REPORTED THAT THERE WAS A REVASCULARIZATION OF THE MID RCA CARRIED OUT APPROX 2.5 YRS POST INDEX PROCEDURE. THERE WAS AN UNK BRAND STENT IMPLANTED DURING REVASCULARIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000658062

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention