MAUDE Adverse Event Report: BRAINLAB AG CRANIAL NAVIGATION SOFTWARE (VERSION 3.1) IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

Model Number 22216-02B

Device Problem Use of Device Problem (1670)

Patient Problem Brain Injury (2219)

Event Date 01/22/2021

Event Type  Injury  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since an electrode was placed in a different path and location in the brain than anticipated appearing in the brainstem, with the brainlab device involved, causing temporary weakness and anisocoria, although according to the surgeon: the deviation of the hippocampal electrode placement was detected with a post-op ct. The outcome of the revision surgery on the same day to correct the placement to the intended position was successful as intended. The burr hole (craniotomy) did not need to be changed or extended, the same existing burr hole was used for the revision surgery. The negative clinical effects were temporary weakness and anisocoria (unequal pupils). The temporary weakness resolved, but the anisocoria was still present when the patient was discharged and it is unknown whether this will be temporary or long-term. There are no other effects reported by the surgeon, neither due to surgery/anesthesia repeat of ca. 90min for the revision. Follow-up exams are intended for this patient. There were no further remedial actions necessary, done or planned for this patient. Hospitalization was not prolonged either. According to the results of the brainlab investigation and the information provided by the hospital, it can be concluded that the root cause of the deviated placement of the hippocampal electrode lead by approximately 18 mm medial from its intended position (at both entry and target points) was most likely a movement of the patient reference array relative to the patient anatomy, e. G. During draping or sterile array exchange, after registration of navigation to the patient anatomy was performed by the user, due to an insufficiently rigid fixation and/or inadvertent forces applied. A movement of the reference array relative to the patient's head, after registration to navigation was performed explains the relatively large, parallel deviation of the electrode lead placement in the medial direction. Reference array movement during the procedure cannot be compensated for by the navigation software and results in a deviated display of the registered preoperative patient image used in navigation, on which tracked instruments are displayed, from the actual patient anatomy. Apparently, the resulting deviation of the navigation display from the patient anatomy was not recognized by the user with the appropriate and necessary accuracy verification checks after draping/sterile exchange and throughout the procedure. There is no indication of a systematic error or malfunction of the brainlab device (navigation). 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 cranial surgery for an electrode placement in the brain, for responsive neurostimulator (rns) system implantation for epilepsy, has been performed with the aid of the brainlab cranial navigation sw 3. 1. A pre-operative ct scan was acquired 1 day before the surgery, to register and use with navigation, and a former mri scan was fused to this ct. Trajectories were planned. During the procedure the surgeon: positioned the patient in a supine orientation with a lateral head tilt in a non-brainlab head holder, and attached the unsterile navigation reference array to the head holder. Performed the image registration with surface matching by acquiring registration points on the patient's skin surface with the softouch to match the display of the navigation to the current patient anatomy. Verified the accuracy of the patient registration to navigation, determined the result as very good, and accepted the registration to proceed. Determined the entry points for the 2 burr holes for the electrodes with the navigated pointer aligned to the planned trajectories, as well as for the craniectomy for the neurostimulator, and marked these on the patient's head. Draped the patient, with exchanging the unsterile reference array to a sterile array, re-verified the marked entry points with the navigated pointer, and created the burr holes and the bone flap. The neurostimulator was placed extradural in the bone flap. For the hippocampal electrode placement, aligned the navigated varioguide to the planned trajectory, opened the dura, inserted a cannula through the varioguide, and the electrode down the cannula to its target. Performed electrode testing detecting the expected impedance levels and eeg signals. Placed the other, strip electrode without use of navigation through the other created burr hole along the right temporal surface. Completed the surgery and closed the patient. A post-op ct revealed that the hippocampal lead appeared in the brainstem, approximately 18mm medial to the planned trajectory. A revision surgery was scheduled, and took place a few hours later on the same day (b)(6) 2021, to correct the hippocampal electrode placement, using the same existing burr hole (craniotomy), and also with the aid of brainlab navigation, though using a different navigation system at this hospital available for the revision surgery. The revision surgery was successful in placing the electrode at the originally intended position. According to the surgeon: the deviation of the hippocampal electrode placement was detected with a post-op ct. The outcome of the revision surgery on the same day to correct the placement to the intended position was successful as intended. The burr hole (craniotomy) did not need to be changed or extended, the same existing burr hole was used for the revision surgery. The negative clinical effects were temporary weakness and anisocoria (unequal pupils). The temporary weakness resolved, but the anisocoria was still present when the patient was discharged and it is unknown whether this will be temporary or long-term. There are no other effects reported by the surgeon, neither due to surgery/anesthesia repeat of ca. 90min for the revision. Follow-up exams are intended for this patient. There were no further remedial actions necessary, done or planned for this patient. Hospitalization was not prolonged either.

• Brand Name: CRANIAL NAVIGATION SOFTWARE (VERSION 3.1)
• Type of Device: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
• 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: markus hofmann ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 11333399
• MDR Text Key: 241077710
• Report Number: 8043933-2021-00011
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481132439
• UDI-Public: 04056481132439
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192703
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 22216-02B
• Device Catalogue Number: 22216C
• Device Lot Number: SW V. 3.1.4
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 02/16/2021 Patient Sequence Number: 1