BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2023551 · Received March 16, 2011

    Report

    Report Number
    9612164-2011-00051
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 15, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: RESULTS: (THE ROOT CAUSE OF THE EVENT IS UNDETERMINED), (OCCLUSION).

    Description of Event or Problem · 1

    THE PHYSICIAN DEPLOYED A 3.0MM DIAMETER X 12MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING CORONARY STENT TO A PT TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING. THE STENT WAS WELL APPOSED TO THE WALL WITH NO STENT MAL-APPOSITION REPORTED. APPROX THREE DAYS LATER, THE PT PRESENTED WITH AN OCCLUSION. INFORMATION PROVIDED CONFIRMS THAT THE PT WAS RESISTANT TO THE PLAVIX ADMINISTERED AND THE PHYSICIAN STATED THAT THE EVENT WAS NOT RELATED TO THE STENT. THE PT IS REPORTED TO BE FINE AND NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0004755744

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization PLAVIX