BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 9769052 · Received February 28, 2020

    Report

    Report Number
    9612164-2020-00934
    Event Type
    Malfunction
    Date Received
    February 28, 2020
    Date of Event
    February 11, 2020
    Report Date
    May 25, 2020
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P160043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    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

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

    Additional Manufacturer Narrative · 1

    CORRECTION: A 6F GUIDING CATHETER WAS USED WITH THE 6F TELESCOPE. THE SPADE-SHAPED MARKERBAND AT THE ENTRY PORT OF THE TELESCOPE WAS ALIGNED WITH THE OUTSIDE OF THE CURVE OF THE DEVICE. IT WAS REPORTED THAT THERE WAS NO WIRE WRAP AROUND THE ENTRY PORT WHEN DELIVERING THE DEVICE. IT WAS REPORTED THAT THE FAILURE TO CROSS THE LESION WITH RESOLUTE ONYX WAS CAUSED BY THE SEVERE CALCIFICATION AND TORTUOSITY. THE WAS INITIALLY REPORTED THAT THE PROCEDURE WAS COMPLETED USING A NON MEDTRONIC STENT. IT WAS SUBSEQUENTLY REPORTED THAT THE PROCEDURE WAS NOT COMPLETED USING THE NON MEDTRONIC STENT BECAUSE OF SEVERE VESSEL TORTUOSITY. IT WAS DECIDED NOT TO ATTEMPT ANOTHER STENT. IT WAS REPORTED THAT THE DEFORMATION OF RESOLUTE ONYX WAS CAUSED BY THE TELESCOPE. IT WAS REPORTED THAT THE DISLODGMENT OF RESOLUTE ONYX WAS CAUSED BY THE SEVERE CALCIFICATION AND TORTUOSITY. 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 ONE 6 FRENCH TELESCOPE GUIDE EXTENSION CATHETER (GEC) AND THREE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS (DES) TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION LOCATED IN THE MID CIRCUMFLEX (CX) ARTERY. THE TELESCOPE GEC WAS REMOVED FROM PACKAGING AND PREPPED PER IFU. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED ON THE THREE RESOLUTE ONYX DES DEVICES. THE LESION WAS PRE-DILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE TELESCOPE. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE THREE RESOLUTE ONYX DES DEVICES. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY OF THE TELESCOPE AND RESOLUTE ONYX (LOT: 0009200737 / PLI 40). EXCESSIVE FORCE WAS USED DURING DELIVERY OF RESOLUTE ONYX (LOT: 0009250482 / PLI 20). IT WAS REPORTED THAT RESOLUTE ONYX WERE STUCK AT THE ENTRY PORT OF THE TELESCOPE. IT WAS STATED THAT THE TELESCOPE GEC WAS CHANGED TO A NON MEDTRONIC GEC AND THERE WAS NO RESISTANCE NOTED AT THE ENTRY PORT. THE RESOLUTE ONYX DES (LOT NO: 0009200737 / PLI 40) WAS UNABLE TO CROSS THE LESION WITH THE NON MEDTRONIC GEC, AND THE PROCEDURE WAS COMPLETED USING A NON MEDTRONIC STENT. IT WAS REPORTED THAT A RESOLUTE ONYX, (LOT: 0009250482 / PLI 20) STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING / ADVANCEMENT. IT WAS REPORTED THAT A RESOLUTE ONYX (LOT: 0009165354 / PLI 30) STENT DISLODGMENT OCCURRED AFTER REMOVAL OF THE DEVICE FROM THE PATIENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234522 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0009165354

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR