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

Model Number TREON

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

Patient Problems Therapeutic Response, Decreased (2271); Iatrogenic Source (2498)

Event Date 02/05/2010

Event Type  Injury  

Manufacturer Narrative

Specific patient identifier not made available by the journal article author.Patient labeled as patient 1 and therefore used.Patient age and weight not made available by the journal article authors.Event date is approximated.Date provided is when the journal article was accepted.Citation: feichtinger, m, pau, m, zemannm w, et al.Intraoperative control of resection margins in advanced head and neck cancer using a 3d-navigation system based on pet/ct image fusion.Journal of cranio-maxillo-facial surgery (2010) 38, 589-594.Doi:10.1016/j.Jcms.2010.02.004, available online at http://www.Sciencedirect.Com.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.Device manufacturing date is unavailable.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.Per the journal article, the width of the resection margin is one of the most important prognostic factors, since having close or positive surgical margins is associated with a high incidence of local recurrence and reduced overall survival.Close margins are a problem because they can only be detected on the specimen postoperatively, when additional resection is not possible.If such a margin cannot be obtained the tumour should be considered to be unresectable.Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's 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 a medtronic representative.Use of the navigation system was reported.This is medical device report (mdr) three of four.See 1723170-2017-04658, 1723170-2017-04659 and 1723170-2017-04689 for other mdrs.This was a prospective study between november 2005 and april 2009.Local recurrent of disease in advanced carcinomas of the head and neck is strongly correlated with the presence of positive or close resection margins after operative treatment.The purpose of this study is to present a new method of assessing resection margins intraoperatively using image-guided surgery based on positron emission tomography/computed tomography (pet/ct) image fusion.It is well known that local tumour control of advanced head and neck cancer mostly depends on the status of the resection margins, which is one of the most important prognostic factors.It has been shown that the incidence of local recurrence in patients having positive surgical margins is twice as high as in those with negative margins.Moreover these patients have a significantly reduced survival rate.It is well established that histological clearance of 5 mm or more is required in cancer resection in order to reduce local recurrence and improve survival (johnson et al.,1997).To achieve this goal a margin of at least 10 mm is recommended at the time of surgery to minimize the risk of underestimation and specimen shrinkage.The intraoperative evaluation of the distance between the resection margins and the tumour margin remains a troublesome issue in oncologic surgery.This is particularly true for advanced tumours infiltrating complex anatomical areas like the masticatory space, the parapharyngeal space or the skull base.Patient no.1 had a maxillary sinus adenoid cystic carcinoma (acc) pathology.The distance between the resection margins and the hypermetabolic areas on intraoperative pet/ct navigation was considered ¿¿not adequate¿¿.Additional image-guided resection was performed in order to reach a minimal tumour distance of 5 mm.Frozen sections were negative for tumour infiltration.The specimen showed a margin between tumour and resection of less than 5 mm.In two of these patients an additional resection allowed for a final satisfactory margin of 5 mm.Unfortunately both presented positive nodes in the neck dissection so they were submitted to adjuvant radiotherapy.The patient is free from disease (ffd).Conclusion: despite the limited number of patients, intraoperative image-guided control of resection margins based on pet/ct image fusion seems to be useful in improving local control of advanced head and neck cancer.Navigating the surgical defect appears to be an effective technique to give an accurate intraoperative measurement of the distance between the resection margins and the tumor.Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's system.There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.

• Brand Name: STEALTHSTATION TREON TREATMENT GUIDANCE 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: oksana ditolla ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7035747
• MDR Text Key: 92155348
• Report Number: 1723170-2017-04688
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• 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: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TREON
• Device Catalogue Number: 9680111
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2017
• 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