BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1923680 · Received December 9, 2010

    Report

    Report Number
    2953200-2010-02485
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    October 29, 2010
    Report Date
    November 10, 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
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: GI BLEED.

    Description of Event or Problem · 1

    TWO ENDEAVOR SPRINT RX DRUG ELUTING STENTS WERE IMPLANTED, ONE IN THE PROXIMAL RCA AND ONE IN THE PROXIMAL LCX. AT 1 MONTH, 6 MONTH, 1 YEAR, 1.5 YEAR, 2 YEAR AND 2.5 YEAR FOLLOW-UP'S PT WAS ASYMPTOMATIC / FREE OF SYMPTOMS. IT IS REPORTED THAT THE PT SUFFERED SPONTANEOUS GASTRO-INTESTINAL BLEED APPROXIMATELY 2.5 YEARS POST INDEX PROCEDURE. PT WAS TAKING CLOPIDOGREL AND ASPIRIN 24 HOURS BEFORE THE EVENT. INVESTIGATOR INDICATED THAT EVENT WAS NOT RELATED TO THE STUDY STENT OR PROCEDURE (REF MFR # 2953200201002486).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000621434

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention