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 03/22/2023

Event Type  Injury  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since an electrode (lead) was placed in a different location in the brain than anticipated, with the brainlab device involved, despite according to the surgeon: the misplaced electrode was detected during the surgery and was replaced (back to) the correct initial position during the very same surgery.The outcome of the surgery was successful as intended.There was no actual harm or negative clinical effect to the patient due to the misplaced electrode, neither due to the prolonged anesthesia of ca.30 minutes.There was no increased or direct risk of harm to the patient due to the misplaced electrode.No further medical/surgical remedial actions were necessary, planned, or done for the patient.Hospitalization was not prolonged either.According to the results of the brainlab investigation and the limited information provided by the hospital, it can be concluded that the main root cause of the misplacement of the electrode is: an automatic rigid fusion result between the intraoperative scan and the pre-operative scan containing the planned electrode trajectory, which was not as accurate as desired/appropriate for this specific surgery, which was accepted by the user due to an insufficient review of the fusion result.Apparently, the insufficient fusion result was not recognized by the user with the necessary verification of the fusion result, prior to proceeding to generate the stereotactic coordinates and placement of the electrode.As the required data for investigation was not made available to brainlab by the hospital for analysis, a specific cause for the less than ideal automatic rigid fusion result cannot be determined.However, the results of any image fusion algorithm strongly 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.Fusion results are influenced by a number of scan properties; without a review of the scans involved brainlab cannot determine the precise cause for the insufficient automatic fusion result.In this specific scenario, based on interviews, the intraoperative scan was reported to have excluded the frontal portion of the face (not following brainlab scan recommendations for fusion/co-registration), and the user was reported to have only verified the scan on one slice (not following brainlab recommendations for thorough review of the fusion result).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.Brainlab intends to reiterate the relevant topics regarding the use of the device to this customer.

Event Description

A stereotactic neurosurgery for bilateral deep brain stimulation (dbs) electrode placement to treat cervical dystonia tremors, was performed with a treatment plan of the brainlab elements image fusion 4.0 and trajectory planning 2.5 software.Placement of two (bilateral) electrodes was planned and performed.One day prior to the surgery, a preoperative mri scan was used with the brainlab elements software to identify the entry and target points (trajectories) for the planned lead placements.During the procedure the surgeon: with the patient anesthetized, fixed a non-brainlab stereotactic frame and localizer to the patient's head, and acquired an intraoperative ct scan.Localized the intraoperative ct scan for the plan to establish a head ring-specific coordinate system for calculation of arc settings for the planned trajectories, and fused it to the existing preoperative mri scan in the preoperative treatment plan using the brainlab image fusion software, creating a co-registration of the intraoperative scan to the preoperative scan, and actively accepted the fusion/co-registration result to proceed.Noted the coordinates of the planned trajectory from the brainlab software for the corresponding non-brainlab stereotactic arc settings.Marked incision entry points on the patient's scalp, draped the patient, and attached the non-brainlab stereotactic arc to the frame.Aligned the arc to the coordinates for the first electrode (lead), made the incision and burr hole at the entry point, and placed the first electrode (lead) through the arc to the planned trajectory.Obtained an intraoperative scan to confirm placement of the lead: performed a new fusion/co-registration of the new intraoperative scan to the preoperative scan in the treatment plan, accepted the accuracy of the fusion to proceed, and used the fused scans to compare the actual lead placement position (as visible in the intraoperative scan) with the planned trajectory from the preoperative scan, and determined the placement of the lead was accurate.Aligned the arc to the coordinates for the second electrode (lead), made the incision and burr hole at the entry point, and placed the second electrode (lead) through the arc to the planned trajectory.Obtained another intraoperative ct to confirm placement of the second lead and noted that a significant portion of the front of the patient's face was missing from the scan.Performed a new fusion/co-registration of the new intraoperative scan to the preoperative scan in the treatment plan, reviewing only one slice of the dataset displayed but not reviewing the entire scan, and accepted the accuracy of the fusion to proceed.Used the fused scans to compare the actual placement of the second lead to the planned trajectory, and determined the lead was placed posterior and medial to the planned position by approximately 5mm, and decided to reposition the electrode.Repositioned the electrode; in the meantime, the brainlab representative who was present reviewed the fusion/co-registration of the scans, and noted some discrepancies which prompted a suspicion that the fusion was not correct.The brainlab representative alerted the surgeon to review the fusion again; upon further review, the surgeon determined the fusion/co-registration was not accurate (not properly aligned), and in fact, the second lead had been placed correctly but only appeared to be misplaced due to the inaccurate fusion.However, at this point the lead had been repositioned to an incorrect location based on the incorrect fusion/co-registration.Repositioned the second electrode back to its initial (correct) location and acquired a confirmation intraoperative ct which showed that both leads were placed correctly.Completed the surgery.According to the surgeon: the misplaced electrode was detected during the surgery and was replaced (back to) the correct initial position during the very same surgery.The outcome of the surgery was successful as intended.There was no actual harm or negative clinical effect to the patient due to the misplaced electrode, neither due to the prolonged anesthesia of ca.30 minutes.There was no increased or direct risk of harm to the patient due to the misplaced electrode.No further medical/surgical remedial actions were necessary, planned, or done for the patient.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: maura pascarella ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 16769187
• MDR Text Key: 313580056
• Report Number: 8043933-2023-00027
• 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: K170816
• 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: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• 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: 26217-02H
• Device Lot Number: SW V. 4.0.2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other