BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2160557 · Received July 6, 2011

    Report

    Report Number
    9612164-2011-00678
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    May 20, 2011
    Report Date
    June 9, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (STENT THROMBOSIS, REVASCULARIZATION).

    Description of Event or Problem · 1

    AN ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENT WAS IMPLANTED IN THE MID RCA. IT IS REPORTED THAT APPROXIMATELY 5 MONTHS POST INDEX PROCEDURE, THE PATIENT HAD SUFFERED WITH PROGRESSIVE ANGINA FOR 1.5 WEEKS AND THERE WAS AN ANGIOGRAM PERFORMED. THE PATIENT WAS FOUND TO HAVE STENT THROMBOSIS AND NINETY-FIVE PERCENT IN-STENT RESTENOSIS OF THE MID RCA. THERE WAS A REVASCULARIZATION CARRIED OUT WHERE THERE WAS ANOTHER BRAND STENT IMPLANTED IN THE MID RCA. IT IS REPORTED THAT THE PATIENT RECOVERED WITH TREATMENT. THE INVESTIGATOR HAS INDICATED THAT THE EVENT WAS DEFINITELY RELATED TO THE STUDY DEVICE AND WAS NOT RELATED TO THE STUDY PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention ASPIRIN| CLOPIDOGREL