MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) POLESTAR INTEGRATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number POLESTAR

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

Patient Problems Brain Injury (2219); Iatrogenic Source (2498); No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2011

Event Type  Injury  

Manufacturer Narrative

The iomri-guided stereotactic biopsies were done on 39 patients. Their age ranged from 5 years to 86 years, with a mean of 49 years. There were 25 male and 14 female patients. Schulder, m. , & spiro, d. (2011) intraoperative mri for stereotactic biopsy. Per article: intraoperative imaging offers several advantages in this regard brain shifts that may occur with dural opening can be accounted for; if a non-lesional frozen section is obtained, repeat imaging and targeting can be done during the same surgery; the surgeon can ensure that the biopsy is taken from the area most likely to yield a diagnosis; with serial imaging during biopsy, unnecessary penetrations with the cannula can be avoided; hemorrhage can be ruled out at the end of the procedure. In conclusion: intraoperative imaging enables the surgeon to compensate for brain shift, to re-image and retarget as necessary, and to rule out intracranial bleeding.

Event Description

Per article, iomri-guided biopsy was done in 39 patients, of whom 28 had neoplasms and 11 had non-neoplastic conditions. Additional or time related to the use of iomri (including positioning of the patient and magnet, and imaging acquisition) averaged 1. 1 h. In 53% of the surgeries the biopsy cannula was repositioned based on intraoperative imaging. A histologic diagnosis was obtained in all but one patient, with iomri confirming proper cannula placement in all cases. There were no significant hemorrhages on clinical or imaging grounds nor any other complications. Biopsies were done using the polestar n-20 iomri (medtronic navigation, (b)(4), usa) under general anesthesia. Images were acquired after patient positioning and after insertion of an mri-compatible biopsy cannula. A navigus guide (medtronic navigation) was used to align and direct the cannula. Retargeting was done as necessary, to improve placement within the target and to avoid critical structures, using the system¿s integrated infrared navigation tool. Cannula placement was tracked using serial images. Diagnoses included high grade glioma in 15 patients, low grade glioma in 11, lymphoma in 1, and embryonal cell carcinoma in 1; and 10 patients had non-neoplastic lesions, including 3 bacterial abscesses. In one patient, although increased cellularity was seen, no definitive diagnosis was made. Intraoperative images showed the biopsy cannula to be within the enhancing component of the lesion (this patient remains neurologically intact, with stable mri findings, 1 year later). Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's polestar integration navigation system. There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.

• Brand Name: POLESTAR INTEGRATION 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: catherine eaton ; 826 coal creek circle; louisville, CO 80027 ; 7208902092
• MDR Report Key: 6559013
• MDR Text Key: 74888039
• Report Number: 1723170-2017-02033
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: POLESTAR
• Device Catalogue Number: 9732702
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2006
• 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: 05/10/2017 Patient Sequence Number: 1

Treatment

(B)(4)