BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN AQM DEVICE

    MDR report key: 24066648 · Received January 14, 2026

    Report

    Report Number
    1226420-2026-00004
    Event Type
    Injury
    Date Received
    January 14, 2026
    Date of Event
    May 23, 2025
    Report Date
    January 14, 2026
    Manufacturer
    MEDTRONIC ADVANCED ENERGY (SALIENT)
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4) 510(K) IS DEPENDENT UPON THE DEVICE MODEL NUMBER AND IS THEREFORE, UNAVAILABLE. H3) NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. 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

    GOSSELIN, L.-E., CHAMPAGNE, P.-O., LAVOIE, P., <(>&<)> NADEAU, S. (2024). DIRECT TUMORAL PUNCTURE EMBOLIZATION OF ONYX BEFORE ENDOSCOPIC ENDONASAL RESECTION OF A MASSIVE JUVENILE ANGIOFIBROMA FOR A PATIENT WITH VON WILLEBRAND DISEASE ¿ A CASE REPORT AND REVIEW OF LITERATURE. INTERNATIONAL JOURNAL OF SURGERY CASE REPORTS, 120, 109784. HTTPS://DOI.ORG/10.1016/J.IJSCR.2024.109784 INTRODUCTION: STANDARD TREATMENT OF A JUVENILE ANGIOFIBROMA (JNA) IS SURGICAL RESECTION, USUALLY WITH AN ENDOSCOPIC ENDONASAL SURGERY AND A PREOPE RATIVE EMBOLIZATION. HOWEVER, STANDARD INTRA-ARTERIAL EMBOLIZATION MAY FAIL TO COMPLETELY DEVASCULARIZE TUMORS. A NOVEL TECHNIQUE OF DIRECT INTRANASAL INTRATUMORAL ONYX EMBOLIZATION HAS BEEN DESCRIBED. THE AIM OF THIS STUDY IS TO DEMONSTRATE THE SAFETY AND THE USEFULNESS OF THIS EMBOLIZATION TECHNIQUE ON A PEDIATRIC CASE OF JNA AND TO COMPARE OUR RESULTS TO PREVIOUSLY REPORTED CASES. PRESENTATION OF CASE: A TWELVE-YEAR-OLD PATIENT SUFFERING FROM VON WILLEBRAND DISEASE PRESENTED WITH A VOLUMINOUS JNA WITH INTRACRANIAL EXTENSION. INTERNAL CAROTID ARTERY (ICA) BRANCHES PARTIALLY VASCULARIZED THE TUMOR. THE PATIENT HAD TWO PREVIOUS INCOMPLETE SURGICAL RESECTIONS, WHICH WERE PRECEDED BY A STANDARD EMBOLIZATION, DUE TO MASSIVE PERIOPERATIVE BLEEDING. DISCUSSION: A DIRECT INTRATUMORAL EMBOLIZATION OF ONYX SAFELY ALLOWED COMPLETE TUMORAL DEVASCULARIZATION. TUMORAL RESECTION WAS THEN COMPLETED BY AN ENDONASAL ENDOSCOPIC APPROACH. SURGERY TIME WAS DECREASED (4,5 H VERSUS 5,5 AND 6,5 H) AND BLOOD LOSS WERE MINIMIZED (300 ML VERSUS 1 L AND 1,3 L). NO COMPLICATION OCCURRED. TWELVE ARTICLES PREVIOUSLY REPORTED THIS EMBOLIZATION TECHNIQUE. WE PRESENT THE FIRST REPORTED CASE OF ONYX EMBOLIZATION BEING USED FOR A PEDIATRIC PATIENT WITH A COAGULATION DISORDER AND A VOLUMINOUS TUMOR. CONCLUSION: A DIRECT INTRATUMORAL ONYX EMBOLIZATION ALLOWED COMPLETE RESECTION OF A MASSIVE JNA, FOR A PATIENT WITH VON WILLEBRAND DISEASE. OUR DATA SUGGEST THAT THIS TECHNIQUE IS SAFE AND MAY BE INSTRUMENTAL FOR A JNA'S RESECTION, EVEN IF LITTLE VASCULARIZATION COMES FROM ICA BRANCHES. 1. "...AFTER A PARTIAL RESECTION OF THE NASOPHARYNX PORTION, AN IMPORTANT TUMORAL BLEEDING COMPELLED SURGEONS TO STOP THE SURGERY. TOTAL BLOOD LOSS WAS 1 L." 2. "THE PATIENT REMAINED HEMODYNAMICALLY STABLE BUT WAS GIVEN TWO TRANSFUSIONS DURING SURGERY." 3. "IN OUR CASE, ONLY A FEW SPARKS WERE SEEN AND DID NOT COMPROMISE THE PROCEDURE'S SAFETY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127434 UNKNOWN AQM DEVICE ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI MEDTRONIC ADVANCED ENERGY (SALIENT) MAE UNK AQM DEV UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Male Other