MAUDE Adverse Event Report: BRAINLAB AG ELEMENTS IMAGE FUSION (VERSION 4.0); SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

Model Number 26217-02H

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2023

Event Type  Injury  

Manufacturer Narrative

B2, h1: a risk to the patient's health could not be excluded for these specific circumstances, since an electrode was placed in a different location in the brain than anticipated, with the brainlab device involved, despite according to the surgeon: - the electrode placed not as intended (at right side, near anterior thalamic nucleus) was corrected/replaced in the very same surgery.- the final outcome of the surgery was successful as intended, with both electrodes placed correctly.- there was no actual harm/negative clinical effect to the patient due to the deviating placement, neither due to the prolonged surgery/anesthesia of 1 hour, despite a direct (or increased) risk to harm a critical structure due to the deviating placement - there were/are no further medical/surgical remedial actions necessary, done or planned for this patient as a result of the deviating placement; hospitalization was not prolonged either.G3, g6: the potential contribution of the brainlab device to the adverse event was only confirmed with the results of the technical investigation as of (b)(6), 2024.H6: according to the results of the brainlab technical investigation and the information provided by the hospital, it can be concluded that the main root cause of the misplacement of one electrode is: -an automatic rigid fusion result between the localizer-ct and the pre-operative mri-plan containing the planned electrode trajectories, which was not as accurate as desired/appropriate for this specific surgery, but which was accepted by the user due to an insufficient review of the fusion result.Fusion results are influenced by a number of scan properties.A review of the scans involved showed an inaccurate fusion between a preoperative small field of view mr and the intraoperative large field of view localizer-ct.The little mutual information in both scans caused the fusion algorithm to not find an accurate match between the data sets and thus led to an inaccurate image fusion.The results of any image fusion algorithm depend on the input data.Thus, it is mandatory that the user reviews any calculated fusion result with the provided tools in multiple slices and all three orientations of the scan.In this case, the user reviewed the fusion only in the axial orientation in the scan (not following brainlab recommendations for thorough review of the fusion result).Another contributing factor (to a lesser extent): -the bad raw image quality and the artifacts visible in the scans.The mris show an artifact of the metal implant on the patient's scull expanding into the patient's brain.The intra-op cts (cone beam) show very homogeneous grey value information within the patient's brain (an appropriate ct would show soft tissue information).For such low-quality scans it might be required to perform a manual fusion (in all three orientations) to fuse the scans accurately.Apparently, the inaccurate fusion result was not recognized by the user with the necessary verification of the fusion result, and was actively accepted by him prior to proceeding to generate the stereotactic arc coordinates and placement of the electrodes.There is no indication of a systematic error or malfunction of the brainlab device.Corresponding brainlab measures to minimize this anticipated risk as low as reasonably practicable are already in place.H7: brainlab intends to re-iterate the relevant topics regarding the use of the device to this customer.

Event Description

A stereotactic neurosurgery (on (b)(6), 2023) for bilateral deep brain stimulation (dbs) electrode placement, has been performed following a treatment plan created with the brainlab planning software brainlab elements image fusion 4.0.2 and stereotaxy 2.5.1.The treatment plan contained three pre-operatively acquired mr scans (fused accurately) and pre-planned trajectories.During the procedure the surgeons: - with the patient anesthetized, fixed a non-brainlab stereotactic frame and localizer to the patient's head, and acquired an intraoperative ct scan - fused it to the treatment plan's existing fusion tree (the pre-operative mr scans) using the brainlab image fusion software, and accepted the fusion result to proceed - localized the intraoperative ct scan for the plan to calculate coordinates of the planned trajectories for the non-brainlab stereotactic arc using the brainlab stereotaxy software - noted the calculated coordinates, removed the localizer box, positioned the patient in a beach chair position, and attached the non-brainlab stereotactic arc to the frame - aligned the arc to the coordinates for the first electrode (right side), made the incision and burr hole at the entry point, placed the first electrode through the arc to the planned trajectory, and acquired a c-arm scan to confirm depth placement of the electrode - aligned the arc to the coordinates for the second electrode (left side), detected that coordinates are asymmetrically towards midsagittal line of the patient's head, thus reviewed the image fusion result previously accepted, and detected an incorrect fusion of ct to mri scans - edited the fusion tree (fused the ct to the most appropriate/large field of view mri data set), verified the fusion result and adjusted manually as necessary - re-planned both trajectories, repeated the localization step, and verified the newly calculated coordinates of both trajectories (by placing the arc and viewing in multiple scans) - removed the placed electrode, and aligned the arc to the new coordinates for this electrode (right side), reusing the existing burr hole, placed the electrode through the arc to the planned trajectory, and acquired a c-arm scan to confirm depth placement of the electrode - aligned the arc to the coordinates for the second electrode (left side), made the incision and burr hole at the entry point, and placed the electrode through the arc to the planned trajectory - acquired a confirmation ct scan, loaded it into the existing treatment plan, fused scans, and compared the actual electrode placement positions with the planned trajectories from the preoperative scan, and determined the placements of the electrodes was accurate - completed the surgery.According to the hospital/surgeon: - the electrode placed not as intended (at right side, near anterior thalamic nucleus) was corrected/replaced in the very same surgery - the final outcome of the surgery was successful as intended, with both electrodes placed correctly - there was no actual harm/negative clinical effect to the patient due to the deviating placement, neither due to the prolonged surgery/anesthesia of 1 hour, despite a direct (or increased) risk to harm a critical structure due to the deviating placement - there were/are no further medical/surgical remedial actions necessary, done or planned for this patient as a result of the deviating placement; hospitalization was not prolonged either.

• Brand Name: ELEMENTS IMAGE FUSION (VERSION 4.0)
• Type of Device: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
• Manufacturer (Section D): BRAINLAB AG; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• Manufacturer (Section G): BRAINLAB AG; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• Manufacturer Contact: andrea miller ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 18621092
• MDR Text Key: 334258056
• Report Number: 8043933-2024-00004
• Device Sequence Number: 1
• Product Code: LLZ
• UDI-Device Identifier: 04056481140816
• UDI-Public: 04056481140816
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212420
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 26217-02H
• Device Catalogue Number: 26217C
• Device Lot Number: SW V. 4.0.2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other