BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2000733 · Received February 16, 2011

    Report

    Report Number
    2953200-2011-00410
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    October 16, 2008
    Report Date
    January 18, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    TWO ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENTS WERE IMPLANTED OVERLAPPING IN THE MID LAD. THERE WAS A THIRD ENDEAVOR SPRINT (RX) IMPLANTED IN THE MID RCA DURING A STAGED PROCEDURE ONE DAY LATER. IT IS REPORTED THAT THE PT SUFFERED AN MI ON THE SAME DAY AS THE STAGED PROCEDURE. PT WAS ASYMPTOMATIC / FREE OF SYMPTOMS AT 30 DAY, 6 MONTH AND 1 YEAR FOLLOW UPS. AT 1.5 YEAR FOLLOW UP HAD STABLE ANGINA. IT IS REPORTED THAT THERE WAS A REVASCULARIZATION OF THE MID RCA CARRIED OUT APPROX 20 MONTHS POST INDEX PROCEDURE. THERE WAS ANOTHER BRAND DRUG ELUTING STENT IMPLANTED IN THE MID RCA DURING REVASCULARIZATION. INVESTIGATOR HAS INDICATED THAT THE EVENT WAS NOT RELATED TO EITHER THE STUDY STENT OR THE STUDY PROCEDURE. PT WAS ASYMPTOMATIC / FREE OF SYMPTOMS AT 2 YEAR FOLLOW UP. (REF MFR # 2953200-2011-00409 AND 2953200-2011-00411.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000782326

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization ASPIRIN| CLOPIDOGREL