MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC MEDTRONIC NAVIGATION INSTRUMENT, STEREOTAXIC

Model Number UNK_NAV_SYS

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

Patient Problems Death (1802); Edema (1820); Hematoma (1884)

Event Date 10/01/2019

Event Type  Death  

Manufacturer Narrative

Patient age is the mean value of patient in the study. Patient gender is the majority value of patients in the study. Patient weight not available from the site. Date of death is the accepted date of publication as the article did not specify the date of death. Event date is the accepted date of the publication. Device lot number, or serial number, unavailable. No parts have been received by the manufacturer for evaluation. Device manufacturing date is dependent on lot number/serial number, therefore, unavailable. If information is provided in the future, a supplemental report will be issued.

Event Description

Citation: anastasios giamouriadis, duranka perera, afshan safdar, francesco vergani, ranjeev bhangoo, richard gullan, & keyoumars ashkan. Safety and accuracy of frameless electromagnetic-navigated (axiem)-guided brain lesion biopsies: a large single-unit study. Acta neurochirurgica (2019) 161: 2 87¿5 259 3 https://doi. Org/10. 1007/s00701-019-04093-y abstract: background: brain biopsies are required to establish a definitive histological diagnosis for brain lesions that have been identified on imaging in order to guide further treatment for patients. Objective: various navigation systems are in use but little up to date evidence is available regarding the safety and accuracy of a frameless, electromagnetic technique to target brain lesions. Methods: data was collected retrospectively on all patients that had brain biopsies at our institution from 01/01/2010 to 31/12/2017. Operation notes, neuropathology reports, and clinical notes on electronic patient record were used to determine whether biopsy of adequate identifiable abnormal tissue was achieved, whether a definitive diagnosis was established, any adverse events occurred, and if a repeat biopsy was carried out. Results three hundred seventy-one axiem(medtronic, minneapolis, usa)-guided brain tumor biopsies were performed in this 8-year period. Three hundred forty-nine (94. 07%) procedures provided definitive tissue diagnosis, 22 (5. 93%) were non diagnostic; in 6 cases (1. 62%), repeat biopsy was performed and adverse events which caused clinical compromise were observed in 4 patients (1. 08%). Conclusions the axiem is a fast, effective, and safe frameless and pinless neuronavigational system. It offers a high degree of accuracy required for the establishment of a definitive diagnosis, permitting optimal further treatment, and thus improving patient outcomes. Reported events: 1. Three patients died from postoperative hematoma and cerebral edema in the region of the biopsy tract within 24 hours. It was noted the patients had a diagnosis of glioblastoma multiforme iv. 2. One patient died from new onset postoperative status epilepticus. It was noted that the patient had diffuse b cell lymphoma.

• Brand Name: MEDTRONIC NAVIGATION
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 9938054
• MDR Text Key: 186998278
• Report Number: 1723170-2020-01175
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes

Device Operator

• Device Model Number: UNK_NAV_SYS
• Device Catalogue Number: UNK_NAV_SYS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/27/2020
• Was Device Evaluated by Manufacturer?: No
• 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: 04/08/2020 Patient Sequence Number: 1