MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION® S7¿; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number 9733858

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

Patient Problem Brain Injury (2219)

Event Date 04/02/2022

Event Type  Death  

Manufacturer Narrative

Patient age is the mean value of patients in the study.Patient gender is the majority value of patient in the study.Patient weight not available from the site.Event date is the online publishing date of the literature article.Device lot number, or serial number, unavailable.510(k) is dependent upon the device model number and therefore, unavailable.No parts have been received by the manufacturer for evaluation.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Fava, a.Russo, p.D, tardivo, v., passeri, t., câmara, b., penet, n., abbritti, r., giammattei, l., mammar, h., bernat, a.L., mandonnet, e., froelich, s.Endoscope-assisted far-lateral transcondylar approach for craniocervical junction chordomas: a retrospective case series and cadaveric dissection.J neurosurg 135 (1335¿1346).Doi: 10.3171/2020.9.Jns202611 endoscope-assisted far-lateral transcondylar approach for craniocervical junction chordomas: a retrospective case series and cadaveric dissection.J neurosurg 135 (1335¿1346).Doi: 10.3171/2020.9.Jns202611 objective craniocervical junction (ccj) chordomas are a neurosurgical challenge because of their deep localization, lateral extension, bone destruction, and tight relationship with the vertebral artery and lower cranial nerves.In this study, the authors present their surgical experience with the endoscope-assisted far-lateral transcondylar approach (ea-flta) for the treatment of ccj chordomas, highlighting the advantages of this corridor and the integration of the endoscope to reach the anterior aspect and contralateral side of the ccj and the possibility of performing occipitocervical fusion (ocf) during the same stage of surgery.Methods nine consecutive cases of ccj chordomas treated with the ea-flta between 2013 and 2020 were retrospectively reviewed.Preoperative characteristics, surgical technique, postoperative results, and clinical outcome were analyzed.A cadaveric dissection was also performed to clarify the anatomical landmarks.Results the male/female ratio was 1.25, and the median age was 36 years (range 14¿53 years).In 6 patients (66.7%), the lesion showed a bilateral extension, and 7 patients (77.8%) had an intradural extension.The vertebral artery was encased in 5 patients.Gross-total resection was achieved in 5 patients (55.6%), near-total resection in 3 (33.3%), and subtotal resection 1 (11.1%).In 5 cases, the ocf was performed in the same stage after tumor removal.Neither approach-related complications nor complications related to tumor resection occurred.During follow-up (median 18 months, range 5¿48 months), 1 patient, who had already undergone treatment and radiotherapy at another institution and had an aggressive tumor (ki-67 index of 20%), showed tumor recurrence at 12 months.Conclusions the ea-flta provides a safe and effective corridor to resect extensive and complex ccj chordomas, allowing the surgeon to reach the anterior, lateral, and posterior portions of the tumor, and to treat ccj instability in a single stage.Reported events: one patient (case 2), who underwent multiple surgeries, previous radiation therapy, tracheostomy, and gastrostomy in another institution before being referred, showed tumor recurrence at 12 months and died 3 months later.

• Brand Name: STEALTHSTATION® S7¿
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 15105349
• MDR Text Key: 296604787
• Report Number: 1723170-2022-01187
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9733858
• Device Catalogue Number: 9733858
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2022
• 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 Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 36 YR
• Patient Sex: Male