BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 8939001 · Received August 28, 2019

    Report

    Report Number
    9612164-2019-03613
    Event Type
    Malfunction
    Date Received
    August 28, 2019
    Date of Event
    August 22, 2019
    Report Date
    October 16, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    UDI-DI
    00643169557130
    PMA / PMN Number
    P160043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT AN ATTEMPT TO DELIVER THE RESOLUTE ONYX WAS UNSUCCESSFUL. A NON-MEDTRONIC GUIDE EXTENSION CATHETER (GEC) WAS INSERTED. ANOTHER ATTEMPT WAS MADE TO DELIVER THE RESOLUTE ONYX, BUT WAS UNSUCCESSFUL. THE VESSEL WAS DILATED WITH A NON-COMPLIANT BALLOON. THE NON-MEDTRONIC GEC WAS REMOVED AND ANOTHER NON-MEDTRONIC GEC WAS INSERTED. THE STENT WAS NOT ON THE BALLOON WHEN THE DEVICE EXITED THE GEC. THE STENT WAS ABLE TO BE RETRIEVED FROM THE GEC. ANOTHER BRAND STENT WAS SUCCESSFULLY DEPLOYED. 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.

    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 SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 80% STENOSIS IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE STENT BECAME DISLODGED INSIDE THE GUIDE LINER EXTENSION CATHETER DURING DELIVERY TO/AT THE LESION. THE STENT WAS ABLE TO BE RETRIEVED. THE PATIENT IS ALIVE WITH NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732959 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0009765659 00643169557130

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR