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 06/14/2022

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 initial reporter (representative for the electrode/lead manufacturer, who was present for the event - with no response or feedback from the hospital to the contrary): the misplaced lead (electrode) was detected via intraoperative imaging and the lead was removed and replaced (with the aid of non-brainlab planning software) during the very same surgery.The outcome of the surgery was successful.There was no actual harm or negative clinical effect to the patient due to the misplaced lead, nor for the prolongation of anesthesia by approx.30-45 minutes.- there was no direct or increased risk of harm to critical structures due to the misplaced lead.- there were no (further) medical or surgical remedial actions necessary, planned, or done for this patient.Hospitalization was not prolonged either.According to the results of the brainlab investigation and the information provided by the hospital, the root cause for the incorrect arc settings provided by the brainlab software leading to the deviation of the electrode lead from the intended target position was an insufficient (inadequate) co-registration (automatic image fusion result proposed by the brainlab software) between the preoperative patient scan on which the trajectories were planned and the intraoperative patient scan which was localized for use with the non-brainlab stereotactic arc, which was insufficiently reviewed by the user.The user accepted the result without any further corrections, which led to a wrong/inaccurate planning result from which only wrong/inaccurate stereotactic arc settings could be derived (for both trajectories).The proposed automatic image fusion result must always be carefully reviewed by the user (clinician) prior to accepting the result and proceeding to generate stereotactic arc settings.A potential contributing factor to the insufficient co-registration was the incomplete intraoperative patient scan imported by the user from the customer's pacs to the brainlab software for co-registration to the preoperative data, which did not fully share the same common anatomical structures of the preoperative data as required.There are many factors that influence a good or bad image fusion - the user always has to review the results and approve them.Instead of resolving issues with insufficient upload performance, awaiting the upload or cancelling the surgery due to incomplete upload of the data, the user proceeded with the planning and realization of the surgery using an incompletely uploaded image set.Apparently, the insufficient co-registration (automatic fusion result) was not recognized by the customer with the necessary verification of fusion result during the planning, prior to placement of the leads, with the review not sufficiently performed.There is no indication of a systematic error or malfunction of the brainlab device (elements planning software).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 deep brain stimulation (dbs) for treatment of epilepsy, 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.Prior to the surgery, preoperative mr scans were used with the brainlab elements software, with the scans fused, 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 scan.Began the upload of data from the (non-brainlab) intraoperative scanner to the non-brainlab pacs system, and noted the progress bar on the intraoperative scanner had started but not completed the upload.Started the download of the intraoperative scan from the pacs to the brainlab elements software (as made available by the pacs to the brainlab software), despite the scan had not fully uploaded to pacs.After the download (from pacs to the brainlab software) was completed, noted that the imported scan only contained 99 out of a total of 192 slices, but proceeded further anyway.Localized the (incomplete) 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 mr scan in the preoperative treatment plan, creating a co-registration of the intraoperative scan to the preoperative scans, 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.Applied these coordinates to the stereotactic arc, noting that it appeared to be very lateral, but proceeding.Created a burr hole in the patient's skull and placed the right electrode (lead) according to the planned trajectory / coordinates.Obtained an intraoperative scan and determined the placement of the right lead was acceptable.Created a second burr hole in the patient's skull and placed the left electrode (lead) according to the planned trajectory/coordinates.Obtained an intraoperative scan and determined the placement of the left lead was not placed according to the intended trajectory (deviation not specified by the user) and was also approximately 7mm past the target.Removed the left lead, and planned a new trajectory in non-brainlab software which calculated new arc settings.The lead was placed again (using the existing burr hole) and determined to be correctly placed at the end of the surgery.Despite brainlab's request to the hospital and surgeon to confirm the below information, no response has been given to brainlab at this point in time.According to the initial reporter (representative of the electrode lead manufacturer, who was present at the surgery): the misplaced lead (electrode) was detected via intraoperative imaging and the lead was removed and replaced (with the aid of non-brainlab planning software) during the very same surgery.The outcome of the surgery was successful.There was no actual harm or negative clinical effect to the patient due to the misplaced lead, nor for the prolongation of anesthesia by approx.30-45 minutes.There was no direct or increased risk of harm to critical structures due to the misplaced lead.There were no (further) medical or surgical remedial actions necessary, planned, or done for this 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: 15218304
• MDR Text Key: 297859722
• Report Number: 8043933-2022-00047
• 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: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: 505
• Type of Report: Initial
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2022
• 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
• Date Manufacturer Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2021
• 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