BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE ONYX OTW

    MDR report key: 8763975 · Received July 5, 2019

    Report

    Report Number
    9612164-2019-02720
    Event Type
    Malfunction
    Date Received
    July 5, 2019
    Date of Event
    July 3, 2019
    Report Date
    September 5, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    UDI-DI
    00643169602342
    PMA / PMN Number
    P160043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE EXPIRATION DATE OF THE DEVICE WAS NOT CHECKED PRIOR TO OPENING AND IMPLANTING. NO MEDICAL/SURGICAL INTERVENTION (E.G. ANTIBIOTICS) WAS REQUIRED AS A RESULT OF THE EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS USED TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. IT WAS REPORTED THAT THE STENT WAS IMPLANTED ((B)(6) 2019) 32 DAYS PAST IT'S EXPIRY DATE ((B)(6) 2019). THE PATIENT IS ALIVE WITH NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556723 RESOLUTE ONYX OTW STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0008661197 00643169602342

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR