BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1222066 · Received November 6, 2008

    Report

    Report Number
    2953200-2008-01018
    Event Type
    Injury
    Date Received
    November 6, 2008
    Date of Event
    April 12, 2008
    Report Date
    October 7, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS/CONCLUSIONS: (SPONTANEOUS GI BLEED). (SPONTANEOUS BLEED). (SECONDARY INTERVENTION).

    Description of Event or Problem · 1

    TWO ENDEAVOR SPRINT DRUG-ELUTING STENTS WERE IMPLANTED, OVERLAPPING. (MFR REPORT# 2953200-2008-01017-01018) PATIENT WAS ASYMPTOMATIC AT 30 DAY FOLLOW UP. INVESTIGATOR REPORTED A SPONTANEOUS GI BLEED OCCURRING TWO MONTHS POST INITIAL STENT IMPLANT, WHILE ON ANTIPLATELET THERAPY. INVESTIGATOR HAS INDICATED THAT EVENT WAS NOT RELATED TO THE STUDY STENT. AT 6 MONTH FOLLOW UP, PATIENT DISPLAYED STABLE ANGINA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention