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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number TREON
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cerebrospinal Fluid Leakage (1772); Headache (1880); Hematoma (1884); Memory Loss/Impairment (1958); Injury (2348); Meningitis (2389); Iatrogenic Source (2498); Nervous System Injury (2689)
Event Date 04/16/2014
Event Type  Injury  
Manufacturer Narrative
Patient information was unavailable from the site. Event date is approximated. Date provided is when the journal article was published. Citation: shigetoshi yano, takuichiro hide, naoki shinojima, yu hasegawa, takayuki kawano, and jun-ichi kuratsu. Endoscopic endonasal skull base approach for parasellar lesions: initial experiences, results, efficacy, and complications. (2014). Surg neurol int. 2014; 5: 51. Pmcid: pmc4014825 doi: 10. 4103/2152-7806. 130901. 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. 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. 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. Device not returned by customer.
 
Event Description
The journal article was forwarded by medtronic representative. Article indicated the use of surgical navigation system. The study was performed between june 2004 and december 2012 for 27 patients with pituitary adenomas. The article reported that 5 patients experienced headache that remitted postoperatively. No patient died due to surgery. Postoperative csf leakage was observed in 7 of the 74 patients, included 5 patients that underwent the anterior extended approach. Four cases required reoperations to reinforce the skull base. The csf leakage were attributable to no mucosal flap in three cases, inadequate mucosal flap size in one case, incomplete adhesion to the skull base in two cases, and infection of reconstruction materials in one case. Repreparation of a wide mucosal flap from the contralateral septum or using fascia in the second operation resolved continuous csf leakage. Three of the seven cases of csf leakage developed meningitis. Two cases of craniopharyngioma with sinusitis were complicated by postoperative meningitis. Hormonal replacement was required in 17 patients, including 10 with craniopharyngioma, 3 with rathke's cleft cysts, and 4 with pituitary adenoma. With regard to vascular injury, avulsion of p1 perforator during resection of the tumor capsule was observed in one case of pituitary adenoma. Although bleeding was coagulated by a bipolar forceps, small infarction was observed in left thalamus and the patient suffered from transient arousal disorder. Anterior cerebral artery injury in the a2 segment occurred in one patient with tuberculum sellae meningioma during tumor dissection from the surrounding vessel. Coagulation and vascular clipping were not performed successfully, so the patient underwent emergency craniotomy to trap the artery. Although small cerebral infarction was observed in the right frontal base, the patient was able to walk by herself in a week. Contusional injury in the left thalamus was observed in the removal of a suprasellar craniopharyngioma. He suffered from transient memory disturbance. Another contusional injury was observed in the pons in the removal of chondroid chordoma extending to brain stem. She suffered from incomplete paralysis of the left extremities for 3 month. Those injuries were seemed to be due to dissection of the tumor from surrounding tissue. Transient abducens nerve palsy was observed in a case of pituitary adenoma extending to the cavernous sinus due to hemorrhage in the residual tumor. Those three cases were classified in neural injuries. Intratumoral hematoma in the remnant tumor under the optic nerve was observed in a recurrent pituitary adenoma 1 week after removal, and incomplete recovery of a visual deficit was noted. Two cases of hydrocephalus (one meningioma and one craniopharyngioma) were observed about a month after initial surgeries. Those three cases were counted as delayed deficits. One patient developed a subcutaneous hematoma in the abdomen after fat graft preparation, and this was counted as a systemic complication. Seven cases (9. 5%) showed postoperative csf leakage. Three cases were early, and surgeon did not apply nasoseptal flaps. The nasoseptal flap was too small in one case, had incomplete contact with the skull base in two cases, and became infected with (b)(6) in one case. After preparing for the wide mucosal flap, we have not observed csf leakage due to incomplete adhesion of the flap except one mrsa infection case. We used sinus balloon to reinforce the contact of mucosal flap in all cases. Indeed sinus balloon may cause incomplete attach to whole flap and result in loosening the pressure at the peripheral part and on the contrary, balloon pressure setting too high may cause flap necrosis. To avoid these disadvantages of the sinus balloon, we filled the gap in sphenoid sinus with fat, then covered mucosal flap with enough amount of fibrin glue and subjected to sufficient pressure to prevent falling the mucosal flap by filling with 5-8 ml of distilled water. By using such a method, we have not experienced flap necrosis nor incomplete attach to the skull base as long as we prepared wide mucosal flap. Because repreparation of a wide mucosal flap from the contralateral septum or usage of the fascia in the second operation resolved continuous csf leakage, preparing a sufficiently wide nasoseptal flap with good blood supply and confirming complete contact of the flap with the skull base are important factors for preventing csf leakage. In our series, four patients (5. 4%) developed postoperative meningitis, including three patients with craniopharyngiomas (two of whom had postoperative csf leakage). The other two patients had sinusitis without csf leakage. Three patients (4. 1%) of 74 cases suffered transient neural injury. In the cases of craniopharyngioma and chondroid chordoma, contusional injuries occurred in the thalamus during removal of the tumor capsule from the third ventricular floor or in the pons during internal decompression of the tumor by ultrasonic aspiration, respectively. Intracavernous hematoma caused incomplete abducens nerve palsy in the removal of pituitary adenoma extended into cavernous sinus. Upon intratumoral decompression for deep tumors, if it is difficult to determine the depth with the endoscope, then ultrasonic aspirator use should be avoided. The incidence rate of vascular injury was 2. 7% (two cases) was similar to previous reports. One case had avulsion of a2 segment of anterior carotid artery during resection of tuberculum sellae meningioma and another had avulsion of p1 perforator during peeling off the capsule of pituitary adenoma extended over the dorsum sellae. What was common to both vascular injuries was an incomplete view of the interface between the tumor and surrounding tissue. Pulling or incision of the tumor prior to complete observation should be avoided. This study summarizes our initial experiences using the endoscopic skull base approach for midline lesions. Although there was obvious learning curve in these procedures, symptom improvement was high, and the complication rate was low; moreover, it seemed to be minimally invasive compared with conventional skull base surgery, especially for anterior skull base and clival lesions.
 
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Brand NameSTEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
Type of DeviceNEUROLOGICAL 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 Key7466359
MDR Text Key106694996
Report Number1723170-2018-01784
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 04/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberTREON
Device Catalogue Number9680111
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 Received03/28/2018
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: 04/26/2018 Patient Sequence Number: 1
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