BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN AQM DEVICE

    MDR report key: 24022095 · Received January 9, 2026

    Report

    Report Number
    1226420-2026-00002
    Event Type
    Injury
    Date Received
    January 9, 2026
    Date of Event
    August 22, 2023
    Report Date
    January 9, 2026
    Manufacturer
    MEDTRONIC ADVANCED ENERGY (SALIENT)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2) PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. A3) PATIENT GENDER IS THE MAJORITY VALUE OF PATIENTS IN THE STUDY. 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

    KLEINIG, T. J., ABOU-HAMDEN, A., LAIDLAW, J., CHURILOV, L., KELLNER, C. P., WU, T., MOCCO, J., LAU, H., ADAMIDES, A., KAVAR, B., DIMOU, J., CRANEFIELD, J., MCDONALD, A., PLUMMER, S., DAVIS, S., & CAMPBELL, B. C. (2023). EARLY MINIMALLY INVASIVE INTRACEREBRAL HEMORRHAGE EVACUATION: A PHASE 2A FEASIBILITY, SAFETY, AND PROMISE OF SURGICAL EFFICACY STUDY. JOURNAL OF NEUROINTERVENTIONAL SURGERY, 16(6), 555¿558. HTTPS://DOI.ORG/10.1136/JNIS-2023-020446. ABSTRACT BACKGROUND SURGICAL TREATMENT OF INTRACEREBRAL HEMORRHAGE (ICH) IS UNPROVEN, ALTHOUGH META-ANALYSES SUGGEST THAT BOTH EARLY CONVENTIONAL SURGERY WITH CRANIOTOMY AND MINIMALLY INVASIVE SURGERY (MIS) MAY BE BENEFICIAL. WE AIMED TO DEMONSTRATE THE SAFETY, FEASIBILITY, AND PROMISE OF EFFICACY OF EARLY MIS FOR ICH USING THE AURORA SURGISCOPE AND EVACUATOR. METHODS WE PERFORMED A PROSPECTIVE, SINGLE ARM, PHASE ILA SIMON'S TWO STAGE DESIGN STUDY AT TWO STROKE CENTERS (10 PATIENTS WITH SUPRATENTORIAL ICH VOLUMES 2:20 ML AND NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) SCORE OF 2:6, AND SURGERY COMMENCING 12 HOURS AFTER ONSET). POSITIVE OUTCOME WAS DEFINED AS; -:50% 24 HOUR ICH VOLUME REDUCTION, WITH THE SAFETY OUTCOME LACK OF SIGNIFICANT ICH REACCUMULATION. RESULTS FROM DECEMBER 2019 TO JULY 2020, WE ENROLLED 10 PATIENTS AT TWO AUSTRALIAN COMPREHENSIVE STROKE CENTERS, MEDIAN AGE 70 YEARS (IQR 65 -74), NIHSS SCORE 19 (IQR 19-29), ICH VOLUME 59 ML (IQR 25-77), AT A MEDIAN OF 227 MIN (IQR 175-377) POST-ONSET. WAS COMMENCED AT A MEDIAN TIME OF 531 MIN (IQR 437-628) POST-ONSET, HAD A MEDIAN DURATION OF 98 MIN (IQR 77-11 0), WITH A MEDIAN IMMEDIATE POSTOPERATIVE HEMATOMA EVACUATION OF 70% (IQR 67-80%). A POSITIVE OUTCOMEWAS ACHIEVED IN 5/5 FIRST STAGE PATIENTS AND IN 4/5 SECOND STAGE PATIENTS. ONE PATIENT DEVELOPED SIGNIFICANT 24 HOUR ICH REACCUMULATION; OTHERWISE, 24 HOUR STABILITY WAS OBSERVED (MEDIAN REDUCTION 71 % (IQR 61-80), 5/9 PATIENTS 15 ML RESIDUAL). THREE PATIENTS DIED, UNRELATED TO SURGERY. THERE WERE NO SURGICAL SAFETY CONCERNS. AT 6 MONTHS, THE MEDIAN MODIFIED RANKIN SCALE SCORE WAS 4 (IQR 3-6) WITH 30% ACHIEVING A SCORE OF 0-3. CONCLUSION IN THIS STUDY, EARLY ICH MIS USING THE AURORA SURGISCOPE AND EVACUATOR APPEARED TO BE FEASIBLE AND SAFE, WARRANTING FURTHER EXPLORATION. 1. ONE PATIENT DEVELOPED SIGNIFICANT 24 HOUR ICH REACCUMULATION; OTHERWISE, 24 HOUR STABILITY WAS OBSERVED (MEDIAN REDUCTION 71 % (IQR 61-80), 5/9 PATIENTS 15 ML RESIDUAL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81611 UNKNOWN AQM DEVICE ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI MEDTRONIC ADVANCED ENERGY (SALIENT) MAE UNK AQM DEV

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Other