MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number S7

Device Problem Insufficient Information (3190)

Patient Problems Cerebrospinal Fluid Leakage (1772); Facial Nerve Paralysis (1846); Hemorrhage/Bleeding (1888)

Event Date 01/05/2018

Event Type  Injury  

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 59 and the consisted of female patients in the study.Therefore 59 years old and female were used.Event date is approximated.Date provided is when the journal article was accepted.Citation: shin m.Shojima m.Kondo k.Et al.Endoscopic endonasal craniofacial surgery for recurrent skull base meningiomas involving the pterygopalatine fossa, the infratemporal fossa, the orbit, and the paranasal sinus.(2018).World neurosurg.(2018) 112:e302-e312.Https://doi.Org/10.1016/j.Wneu.2018.01.041.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 actual product used for this study is unknown.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.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.Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's surgical navigation system.There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.

Event Description

The attached journal article was forwarded by medtronic representative.Article indicated the use of surgical navigation system.Objective: skull base meningiomas carry a nonnegligible risk of recurrence.In particular, those arising from the sphenoid wings or middle cranial fossa penetrate into extracranial regions, uncommonly showing massive expansion into the craniofacial regions on recurrence.The role of endoscopic endonasal surgery for those intractable lesions remains unclear.Methods: we performed endoscopic endonasal craniofacial surgery for 8 recurrent meningiomas invading into the pterygopalatine fossa, infratemporal fossa, nasopharynx, paranasal sinus, or orbit, comprising 2 meningothelial and 1 fibrous meningiomas (world health organization [who] grade i), 3 atypical and 1 clear cell meningiomas (grade ii), and 1 anaplastic meningioma (grade iii).All were large (15e80 cm3; median, 45 cm3) and highly vascularized.Results: all 8 tumors were sufficiently resected.Gross total resection of the craniofacial part of the lesions was achieved in 5 patients (62.5%).In 3 patients with who grade i meningiomas and 1 with grade ii, tumors were successfully controlled as of the last follow-up.In 4 patients with who grade ii or iii meningiomas, craniofacial lesions were controlled, whereas original intracranial lesions were poorly controlled and became critical.Conclusions: we consider the endoscopic endonasal approach as an acceptable, less-invasive alternative for recurrent craniofacial meningioma.Although all these cases were relatively large and highly vascularized, preoperative endovascular embolization of the feeding arteries contributes to significantly reducing vascularity of the tumors, and local control of the craniofacial lesions was successfully achieved in all cases.Endoscopic endonasal craniofacial surgery enabled sufficient mass reduction without disfiguring facial incisions.Reported adverse event: a (b)(6) male surgical intervention due to significant blood loss with initial resection.A (b)(6) female showed numbness of facial sensation with dry eye, resolved within 3 months.A (b)(6) male intracranial lesion was poorly controlled, csf dissemination.A (b)(6) female intracranial lesion was poorly controlled, csf dissemination.A (b)(6) female intracranial lesion was poorly controlled.

• Brand Name: STEALTHSTATION S7 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 ; navigation customer quality; 826 coal creek circle; louisville, CO 80027 ; 7208903200
• MDR Report Key: 7782745
• MDR Text Key: 117136369
• Report Number: 1723170-2018-04052
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2018
• 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 Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 59 YR