BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3934015 · Received July 15, 2014

    Report

    Report Number
    9612164-2014-00949
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    October 7, 2011
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: FAILURE TO FOLLOW INSTRUCTIONS (RECOMMENDED THAT SHELF LIFE BE VERIFIED PRIOR TO USE); SHELF LIFE EXCEEDED; NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED (DEVICE OR PROCEDURAL IMAGES WERE NOT RETURNED FOR REVIEW). EVALUATION CONCLUSIONS: FAILURE TO FOLLOW INSTRUCTIONS (RECOMMENDED THAT SHELF LIFE BE VERIFIED PRIOR TO USE); NO DEVICE FAILURE; USER ERROR CONTRIBUTED TO EVENT (RECOMMENDED THAT SHELF LIFE BE VERIFIED PRIOR TO USE). (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT AN ENDEAVOR SPRINT DRUG ELUTING STENT WAS IMPLANTED APPROXIMATELY 40 DAYS PAST ITS EXPIRATION DATE IN THE RCA VESSEL OF A PATIENT. NO PATIENT INJURY OR OTHER SEQUELAE WERE REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412435 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0001109705

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR