MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number TREON

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Hemorrhage, Subdural (1894); Iatrogenic Source (2498)

Event Date 03/11/2017

Event Type  Death  

Manufacturer Narrative

Patient identifier and weight were unavailable from the attached journal article or by the authors. Patient age and patient sex not made available the attached journal article or by the authors. The article reports that the mean patient age was 52 and the consisted of 18 male and 48 female patients in the study. Therefore (b)(6) years old and female were used. The date of death is unknown, so the date of accepted was used. Event date is approximated. Date provided is when the journal article was accepted. Citation: shamik chakraborty, salvatore zavarella, sussan salas and michael schulder. Intraoperative mri for resection of intracranial meningiomas. (2017). Journal of experimental therapeutics and oncology, vol. 12, pp. 157-162 the exact system information could not be determined as it was not provided. However, the system listed on this form was at the address listed in the article during the time some of the surgeries were completed. Device udi not provided as this product is no longer manufactured. Device manufacturing date is dependent on lot number/serial number, therefore, unavailable. Multiple attempts have been made to obtain additional information. No further information provided in the journal article or from the authors. The author could not provide any additional information or insight as he was not at the site when the surgeries were performed. No request for service have been received from the customer regarding these events. No parts have been replaced or returned to the manufacturer for evaluation. Per the journal article, author reported that no evidence of infarct seen on the intraoperative scan, therefore they believe it occurred after surgery. Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's imaging system. There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event. Not returned by customer.

Event Description

The attached journal article was forwarded by a medtronic representative. Use of imaging system was reported. This is medical device report (mdr) one of two. For the second mdr, see 1723170-2018-01092. Over a ten-year period, 70 operations were performed on 66 patients with intracranial meningiomas using the medtronic imaging system. The mean age was 52 years with 18 male and 48 female. There was one patient mortality in a patient who had a right sphenoid wing meningioma resected and suffered a severe stroke one day postoperatively. There was no evidence of infarct seen on the intraoperative scan, so we believe it occurred after surgery. In all other patients, postoperative diagnostic mri was concordant with findings on intraoperative images. Up to 15. 7% of patients had surgery positively affected by intraoperative imaging either improving the resection or avoiding unnecessary additional dissection which could potentially harm critical neurologic structures.

• Brand Name: STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: koko tyler ; 826 coal creek circle; louisville, CO 80027 ; 7208903200
• MDR Report Key: 7329155
• MDR Text Key: 102063369
• Report Number: 1723170-2018-01088
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• 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: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: TREON
• Device Catalogue Number: 9680111
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/14/2018
• 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: Reuse

Patient Treatment Data

Date Received: 03/09/2018 Patient Sequence Number: 1