BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT OTW CORONARY STENT SYSTEM

    MDR report key: 2160566 · Received July 6, 2011

    Report

    Report Number
    9612164-2011-00687
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    May 8, 2011
    Report Date
    June 10, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL: RESULTS: (CVA/STROKE). EVAL: CONCLUSION: NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    THE PT HAD ONE ENDEAVOR SPRINT OTW STENT IMPLANTED ON THE DAY OF THE INDEX PROCEDURE IN THE MID RCA. A STAGED PROCEDURE WAS ALSO PERFORMED IN THE MID LCX AND THE PT HAD ANOTHER ENDEAVOR SPRINT OTW IMPLANTED. IT WAS REPORTED THAT APPROX ONE MONTH AFTER THE INDEX PROCEDURE THE PT SUFFERED FROM CARDIAC ARRHYTHMIA AND SICK SINUS SYNDROME AND HAD A LOOP RECORDER INSERTED DUE TO SYSTEMATIC CARDIAC ARRHYTHMIAS. IT WAS STATED THAT THE EVENT HAD A REMOTE RELATIONSHIP TO THE STUDY DEVICE/DRUG/PROCEDURE. SIX MONTHS FROM THE INDEX PROCEDURE, THE PT HAD AN EPISODE OF LEFT SIDED WEAKNESS AND DIFFICULTY WITH SPEECH. CT SCAN OF HEAD SHOWED NO ACUTE FINDINGS. PT STATES SYMPTOMS IMPROVED QUICKLY AND WERE COMPLETELY RESOLVED. REFERENCE MFR REPORT NUMBER 9612164201100686.

    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 58 YR Required Intervention CLOPIDOGREL| ASPIRIN