BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONYX FRONTIER

    MDR report key: 21167208 · Received January 16, 2025

    Report

    Report Number
    9612164-2025-00294
    Event Type
    Malfunction
    Date Received
    January 16, 2025
    Date of Event
    January 13, 2025
    Report Date
    March 13, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    UDI-DI
    00763000511326
    PMA / PMN Number
    P160043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID UNK-CV-GWY-TEL (UNKNOWN SERIAL/LOT); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THE TELESCOPE GEC DEVICE WAS INSPECTED BEFORE USE WITH NO ISSUES NOTED. THE TELESCOPE GEC DEVICE WAS PREPPED PER IFU WITH NO ISSUES NOTED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE DELIVERY OF ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO THE LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY, THE STENT DISLODGED INSIDE A TELESCOPE GUIDE EXTENSION CATHETER (GEC). WHILE ADVANCING THE STENT THROUGH THE GEC INTO THE LAD, THE STENT WAS NOT SEEN ON THE DELIVERY BALLOON, AND IT WAS REALIZED THAT THE STENT HAD DISLODGED INSIDE THE GEC. THE GEC, ALONG WITH THE DISLODGED STENT, STENT DELIVERY SYSTEM, AND THE WIRE WERE REMOVED FROM THE PATIENT. THE STENT WAS SUCCESSFULLY REMOVED WHILE INSIDE THE GEC. THE ONYX FRONTIER DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892623 ONYX FRONTIER STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND ONYXNG25026UX 0012464066 00763000511326

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown