BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2061477 · Received March 16, 2011

    Report

    Report Number
    9612164-2011-00057
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 2011
    Manufacturer
    MEDTORNIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION, RESULTS: IFU INSTRUCTIONS NOT FOLLOWED. NON-STERILE POUCH COMPONENT PLACED ON STERILE TABLE. EVALUATION, CONCLUSIONS: IFU INSTRUCTIONS NOT FOLLOWED.

    Description of Event or Problem · 1

    THE PHYSICIAN WANTED TO IMPLANT A 3.0 MM DIAMETER X 24 MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT TO TREAT A LESION IN A PT. THE NON-STERILE POUCH COMPONENT OF THE ENDEAVOR SPRINT DEVICE WAS PLACED ON THE STERILE TABLE AND THE DEVICE WAS SUBSEQUENTLY USED IN THE PT. THIS WAS NOTED FOLLOWING USE OF THE DEVICE. THE PT WAS GIVEN AN ANTIBIOTIC. NO CLINICAL SEQUELAE HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTORNIC IRELAND NA 0002832973

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK