BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1972377 · Received January 25, 2011

    Report

    Report Number
    2953200-2011-00172
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    March 3, 2011
    Report Date
    February 8, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (MI).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUFFERED AN MI APPROXIMATELY 3.5 MONTHS POST THE INDEX PROCEDURE. INVESTIGATOR ASSESSED THAT THE MI EVENT WAS DEFINITELY RELATED TO THE STUDY DEVICE. IT WAS ALSO REPORTED THAT APPROXIMATELY 3.5 MONTHS POST INDEX PROCEDURE THE PATIENT WAS RE HOSPITALIZED DUE TO RECURRENT ANGINA. RESTENOSIS WAS CONFIRMED AND CABG WAS PERFORMED. INVESTIGATOR ALSO REPORTED THAT THE RESTENOSIS EVENT WAS DEFINITELY RELATED TO THE STUDY STENT AND UNRELATED TO THE PROCEDURE. THE OUTCOME OF THE CABG WAS SUCCESSFUL.

    Description of Event or Problem · 1

    A 3.0MM DIAMETER X 18MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG- ELUTING CORONARY STENT WAS DEPLOYED IN THE PROX LAD OF A PT WITH NO ISSUE REPORTED; HOWEVER, IT WAS REPORTED THAT THE PT HAD AN MI ONE DAY POST IMPLANT OF THE RELEVANT STENT. NO OTHER CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0001031884

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR ASA| CLOPIDOGREL