BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2230851 · Received August 26, 2011

    Report

    Report Number
    9612164-2011-01020
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 16, 2012
    Manufacturer
    MEDTRONIC IRELAND
    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). EVAL: RESULTS: (MI).

    Description of Event or Problem · 1

    PT REC'D A 2.5MM DIAMETER X 24MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING CORONARY STENT IN THE 1ST DIAGONAL AND ONE ENDEAVOR SPRINT RX STENT IN THE LEFT MAIN (DETAILS UNK). STENT IMPLANT WAS SUCCESSFUL; HOWEVER IT WAS REPORTED THAT THE PT SUFFERED AN MI ONE DAY POST PROCEDURE. IT WAS REPORTED THAT THE PT WAS ASYMPTOMATIC ON DISCHARGE. INVESTIGATOR REPORTED THAT THE EVENT WAS UNRELATED TO THE STUDY STENT AND PROBABLY RELATED TO THE PROCEDURE. IT WAS REPORTED THAT THE PT PRESENTED WITH SYMPTOMS OF RECURRENT ANGINA APPROX 1 MONTH POST INDEX PROCEDURE. NTVR WAS PERFORMED. NO OTHER CLINICAL SEQUELAE WERE REPORTED. (REF MFR # 9612164201101019).

    Description of Event or Problem · 1

    DURING RE-PTCA ONE MONTH POST INDEX PROCEDURE TARGET LESION WAS ALSO TREATED. AN ENDEAVOR STENT WAS IMPLANTED SUCCESSFULLY. THE INVESTIGATOR INDICATED THAT THE REPORTED EVENT WAS UNRELATED TO THE STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0003134626

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization NITRATE| ACE| DIURETIC| CLOPIDOGREL| LIPID LOWERING DRUG| BETA| ASA