MAUDE Adverse Event Report: BRAINLAB AG BRAINLAB ELEMENTS IMAGE FUSION (VERSION 4.0); PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

Model Number 26217C

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

Patient Problems Radiation Overdose (1510); Radiation Underdose (2166)

Event Date 03/13/2020

Event Type  Injury  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since apparently radiation was delivered to a target volume that did not correspond to the intended treatment location/size, with the brainlab device involved, and there was a negative effect to the patient (one metastasis continued to grow), although there is no indication of a systematic error or malfunction of the brainlab device, and corresponding brainlab measures to minimize this anticipated risk as low as reasonably practicable are already in place.According to the results of the technical investigation and the information provided by the hospital, it can be concluded that the main root cause for the deviation of intended versus actually irradiated target volume is: using an inappropriate image set for dose planning (apparently insufficient review of rigid/elastic image fusion results led to accepting an elastically deformed mr inappropriate for the intended treatment), which finally led to irradiating a larger area than intended for one metastasis (with lower dose than intended delivered to the metastasis, and higher dose than intended delivered to healthy brain tissue).Apparently the inappropriate rigid/elastic image fusion results were not detected by the user, with the corresponding verification tools provided by the software, before performing dose planning and radiation treatment.The user himself acknowledged insufficient review of fusion results before further treatment planning/radiation delivery.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 re-iterate the relevant topics regarding the use of the device to this customer.

Event Description

A srs treatment for 2 metastases in the left parietal and left occipital lobe in the brain, performed on (b)(6) 2020, had been planned with the aid of brainlab image fusion 4.0 (and brainlab multiple brain mets srs 2.0).During planning/treatment the user: performed a rigid fusion of a mr and ct image set (to combine the information contained within the individual image sets).Proceeded with calculation of an elastic fusion for this mr/ct fusion pair (a new mr image set is generated using a deformable registration algorithm, by brainlab cranial distortion correction).Reviewed and accepted the resulting elastically deformed / distortion corrected mr (incl.Distortion corrected objects).Created a dose plan based on the distortion corrected mr and ct image set irradiated the metastases according to the dose plan.Suspected on (b)(6) 2020, for one metastasis, a deviation of actual metastasis location/size vs.Irradiated target volume, by comparing aforementioned image sets and a post-treatment mr via rigid fusion.According to the hospital: the treatment was a srs treatment (1 fraction), 2 brain metastases, 20-24 gy.One metastasis (left parietal) was not irradiated as intended, the second metastasis (left occipital) treated with this same plan seems to be resolved.For the affected metastasis, a larger volume was treated than what corresponded to the real metastasis size (the metastasis received 50%-71% of the intended dose distribution, and approx.0.35 cc of healthy brain tissue received unintended radiation dose).The incorrect dosage exceeded clinically acceptable limits, and there was a negative clinical effect to the patient (the affected metastasis continued to grow).If further remedial actions are needed is currently undecided.8 more metastases were treated on (b)(6) 2020 and the physician will monitor the patient and the affected metastasis).

• Brand Name: BRAINLAB ELEMENTS IMAGE FUSION (VERSION 4.0)
• Type of Device: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
• Manufacturer (Section D): BRAINLAB AG; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• Manufacturer (Section G): BRAINLAB AG; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• Manufacturer Contact: andrea miller ; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• MDR Report Key: 10151378
• MDR Text Key: 201089524
• Report Number: 8043933-2020-00026
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 26217C
• Device Catalogue Number: 26368C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2019
• 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