MAUDE Adverse Event Report: VITAL IMAGES, INC. VITREA CT BRAIN PERFUSION; PICTURE ARCHIVING AND COMMUNICATION

Model Number VERSION 6.5.5

Device Problems Computer Software Problem (1112); Application Program Problem (2880)

Patient Problem Infarction, Cerebral (1771)

Event Date 08/25/2015

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing with user facility.

Event Description

On (b)(6) 2015, vital customer support received a call from (b)(6) regarding display of incorrectly inverted brain perfusion color maps (cbf and mtt) on our vitrea ct brain perfusion 4d software application.The reporter indicated that a delay in patient treatment had occurred because of the issue.Again on (b)(6) 2015, the same reporter informed our customer support team regarding another patient issue with the software in which the ct brain perfusion result from our software was not in agreement with the performed mr results.The mri showed an obvious stroke (infarct), while the ct perfusion results on our software did not.The patient was treated based on mri results.

Manufacturer Narrative

The customer has provided us two datasets to investigate.The results of the investigation identified two separate issues.Issue #1: unexpected mtt/cbf maps.This customer stated the mtt/cbf maps appear to be inverted.The investigation shows the dataset has a truncated scan, the time-density graph shows that there is not enough washout for our software to produce accurate results.From our neuro education and reference guide (vpmc-13505 a, page 122), we state "caution: factors that can affect the accuracy of the results are: ·not fully capturing the contrast bolus (including at least 2 seconds of pre-enhancement images and post-enhancement)." also, from our neuro education and reference guide (vpmc-13505 a, page 128), we instruct the user to review the time-density graph.Additionally, from our neuro education and reference guide (vpmc-13505 a, page 152), we provide examples of optimal and sub-optimal time-density graphs.In conclusion: the software has behaved as it is designed.Due to incomplete data, the perfusion results could not have been calculated accurately, although the software did produce accurate results with respect to the incomplete data.The software is designed to assist the user in this situation by prominently displaying the time-density graph and by providing accurate instructions for use on how to interpret the time-density graph.Issue #2: ct perfusion results do not agree with mr results for this issue, the user stated they were not confident in the results provided by our software and proceeded to perform an mr scan to obtain additional information.When the user reviewed the mr scan data, a clear infarct was shown, which was not shown by the ct perfusion results.A detailed investigation was done, the summary results are: the ct perfusion results from our software are in agreement with another vendor's algorithm, which suggests our software generated the results accurately based on the data.Additionally, a visual review of the cta data shows that the ct perfusion results are in agreement with the cta data, which suggests the software generated results accurately.

Event Description

On 08/25/2015, vital customer support received a call from (b)(6) regarding display of incorrectly inverted brain perfusion color maps (cbf and mtt) on our vitrea ct brain perfusion 4d software application.The reporter indicated that a delay in patient treatment had occurred because of the issue.Again on 08/26/2015, the same reporter informed our customer support team regarding another patient issue with the software in which the ct brain perfusion result from our software was not in agreement with the performed mr results.The mri showed an obvious stroke (infarct), while the ct perfusion results on our software did not.The patient was treated based on mri results.

• Brand Name: VITREA CT BRAIN PERFUSION
• Type of Device: PICTURE ARCHIVING AND COMMUNICATION
• Manufacturer (Section D): VITAL IMAGES, INC.; 5850 opus pkwy suite #300; minnetonka MN 55343
• Manufacturer (Section G): VITAL IMAGES, INC.; 5850 opus pkwy. suite #300; minnetonka MN 55343
• Manufacturer Contact: alexis erazo ; 5850 opus pkwy. suite #300; minnetonka, MN 55343 ; 9524879774
• MDR Report Key: 5101924
• MDR Text Key: 26728928
• Report Number: 2134213-2015-00001
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup
• Report Date: 12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VERSION 6.5.5
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other