BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT OTW CORONARY STENT SYSTEM

    MDR report key: 2141060 · Received June 21, 2011

    Report

    Report Number
    9612164-2011-00606
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 25, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION, RESULTS: GI BLEED. EVALUATION CODES, CONCLUSION: NO CONCLUSION CAN BE DRAWN (BASED ON THE INFORMATION PROVIDED NO ROOT CAUSE CAN BE DETERMINED).

    Description of Event or Problem · 1

    ONE ENDEAVOR SPRINT OVER THE WIRE DRUG ELUTING STENT WAS IMPLANTED IN THE MID RCA DURING INDEX PROCEDURE. APPROXIMATELY 9 WEEKS POST INDEX PROCEDURE THE PT NOTED A SMALL AMOUNT OF BLOOD IN THE STOOL. A DIAGNOSTIC ENDOSCOPY WAS PERFORMED BUT NO ACTIVE BLEEDING WAS FOUND. A BIOPSY WAS TAKEN. PT IS REPORTED TO HAVE RECOVERED WITH TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R PRASUGREL| ASPIRIN