BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 8481727 · Received April 4, 2019

    Report

    Report Number
    9612164-2019-01157
    Event Type
    Malfunction
    Date Received
    April 4, 2019
    Date of Event
    April 2, 2019
    Report Date
    September 20, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    UDI-DI
    00643169557024
    PMA / PMN Number
    P160043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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

    ADD'L INFO: THE LESION WAS A HEAVILY CALCIFIED LESION LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE VESSEL WAS HIGHLY TORTUOUS (SHEPARD¿S HOOK). NO DIFFICULTIES WERE NOTED WHEN REMOVING THE PROTECTIVE SHEATH. THE STENT WAS INSPECTED POST REMOVAL OF THE PROTECTIVE SHEATH, WITH NO ISSUES NOTED. THE LESION WAS SUCCESSFULLY PRE-DILATED. IT WAS REPORTED THAT THE DEVICE WOULD NOT CROSS THE LESION. IT WAS DECIDED TO REMOVE THE STENT DELIVERY CATHETER AND ATTEMPT ANOTHER BALLOON DILATION. UPON REMOVING THE STENT FROM THE LESION, THE NON-MEDTRONIC GUIDE EXTENSION CATHETER (GEC) WAS ACROSS THE SHEPARD'S HOOK (TORTUOUS VESSEL) TO AID DELIVERY AND REMOVAL. WHEN THE PROXIMAL EDGE OF STENT CAME INTO CONTACT WITH THE GEC, RESISTANCE WAS NOTED. A FURTHER ATTEMPT WAS MADE TO RETRACT THE STENT DELIVERY CATHETER, AND AT THAT POINT STENT DISLODGEMENT WAS NOTED. THE DECISION WAS MADE TO RETRACT THE WIRE, STENT DELIVERY AND GEC. THE DISLODGED STENT WAS CONTAINED WITHIN THE GEC. THE GEC WAS REMOVED FROM THE PATIENT WITH THE DISLODGED STENT INSIDE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY. . 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

    DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION LOCATED IN THE RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. THE DISLODGED STENT WAS CONTAINED WITHIN THE NON-MEDTRONIC GUIDE EXTENSION CATHETER. THE NON-MEDTRONIC GUIDE EXTENSION CATHETER WAS REMOVED FROM THE PATIENT WITH THE DISLODGED STENT INSIDE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275266 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0008980296 00643169557024

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR