BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1222058 · Received November 6, 2008

    Report

    Report Number
    2953200-2008-01016
    Event Type
    Injury
    Date Received
    November 6, 2008
    Date of Event
    September 29, 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
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: (MYOCARDIUM INFARCTION, THROMBOSIS).

    Description of Event or Problem · 1

    ONE ENDEAVOR SPRINT DRUG-ELUTING STENT WAS IMPLANTED IN THE MID RCA. IT IS REPORTED THAT PATIENT WAS HOSPITALIZED ON 56 DAYS LATER DUE TO ACUTE CORONARY SYNDROME. AN ACUTE NON-STEMI IS REPORTED TO HAVE OCCURRED. AFTER BEING IN THE HOSPITAL FOR SEVEN DAYS, AN ANGIOGRAPHY SHOWED IN-STENT THROMBOSIS. THROMBOSIS IS REPORTED TO HAVE OCCURRED IN THE MID RCA. DIAMETER OF STENOSIS WAS REPORTED TO BE >70%. A PTCA REVASCULARIZATION (BALLOON ONLY) OF THE MID RCA IS REPORTED TO HAVE TAKEN PLACE, DUE TO RESTENOSIS AFTER PREVIOUS PTCA. INVESTIGATOR HAS INDICATED THAT EVENT WAS RELATED TO STUDY STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000563174

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention