BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2190326 · Received July 21, 2011

    Report

    Report Number
    9612164-2011-00803
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    January 12, 2011
    Report Date
    June 22, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: (BASED ON THE INFO PROVIDED NO ROOT CAUSE CAN BE DETERMINED), (DISSECTION).

    Description of Event or Problem · 1

    AN ENDEAVOR SPRINT RAPID EXCHANGE DRUG ELUTING STENT DIAMETER 3MM LENGTH 12MM WAS DEPLOYED IN THE RIGHT POSTERIOR LATERAL ARTERY. AS A HEMATOMA WAS CONFIRMED AT THE PROXIMAL EDGE OF THE RIGHT POSTERIOR LATERAL ARTERY, AN ADD'L ENDEAVOR SPRINT RAPID EXCHANGE DRUG ELUTING STENT DIAMETER 3.5 LENGTH 12MM WAS DEPLOYED. ANOTHER ENDEAVOR SPRINT RAPID EXCHANGE DRUG ELUTING STENT WAS ALSO IMPLANTED IN THE PROXIMAL RCA. NO ADD'L CLINICAL SEQUELAE WERE REPORTED. PT IS IN REMISSION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R ASPIRIN AND| CLOPIDOGREL.