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

Model Number S7

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

Patient Problems Intracranial Hemorrhage (1891); Iatrogenic Source (2498)

Event Date 08/30/2016

Event Type  Injury  

Manufacturer Narrative

Patient weight was not provided by the journal article surgeon/author.The event was reported to have occurred over a 2.5 year period, january 2013 to june 2015, when the ommaya reservoirs were placed.The article was accepted on 08/30/2016.Further details regarding the patient complication was requested from the authors, but not provided.Arthur wang, michael s.Tenner, michael e.Tobias, avinash mohan, dolly kim, adesh tandon."arthur wang, michael s.Tenner, michael e.Tobias, avinash mohan, dolly kim, adesh tandon." world neurosurg.(2016) 96:195-201.Http://dx.Doi.Org/10.1016/j.Wneu.2016.08.127 device manufacturing date, unavailable.The journal article discusses that hemorrhage is a known inherent risk of procedure.Oncology patient have hematologic disorders which would predispose them to bleeding and an overwhelming majority have small to slit ventricles that make the ommaya placement more difficult.Complications with ommaya reservoir placement include hemorrhage, suboptimal positioning of the ventricular catheter, proximal malfunction of the catheter, and infection.The article concludes that neuroendoscopy combined with frameless stereotaxy improves catheter accuracy in a subgroup of patients whose ventricular size and anatomy would pose a challenge to either technique used alone.The study shows improved ventricular catheter accuracy compared with national published averages while significantly lowering complication rates.Further studies should investigate long-term follow-up and surgeon learning curve in handling the neuroendoscope.Despite these limitations, we have shown that neuroendoscopy combined with stereotaxy is an effective and feasible technique for ommaya catheter insertion in patients who have small or dysmorphic ventricles.In experienced hands, this dual approach is simple and effective, does not add significant time to the surgical case, and results in a more precise placement of ventricular catheters.Customer has not requested service for the system regarding this event.No parts have been returned for analysis.No alleged device problem.Therefore, no evaluation will be performed.Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that likely utilized medtronic navigation's electromagnetic navigation system.There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.

Event Description

Per journal article, an oncology patient, case number 19 underwent electromagnetic-guided neuroendoscopic placement of ommaya reservoirs.This (b)(6) female patient required a second pass to cannulate the frontal horn after suboptimal cerebrospinal fluid (csf) return was observed and acute hemorrhage was encountered intraoperatively.This patient had a catheter-related intraparenchymal hemorrhage along the ventricular catheter tract that was seen on postoperative imaging related to thrombocytopenia.No postoperative neurologic deficits were seen.Using an axiem stealth stylet, the patient was registered with the specially acquired preoperative ct scan using the stealth workstation.Accuracy was confirmed by evaluating errors of the position of the stylet from the external auditory canal, nasion, and medial and lateral canthi.Accuracy was within 2 mm of the chosen target.The lateral ventricle was cannulated under the computer¿s guidance mode.Computer tracking of the stylet/catheter unit enabled accurate placement of the catheter with real-time monitoring.All patients remained neurologically intact postoperatively.All ventricular catheters were successfully placed into the ipsilateral (84%) or contralateral (16%) foramen of monro.A single ventricular catheter pass was needed to cannulate the ventricle in 96% of patients or 24 of the 25 patients.The mean accuracy was 4.09 +/- 3.47 mm from the target, the ipsilateral foramen of monro.Analysis of the individual dimensions reveals that the catheter tip was within 10 mm of the target in each of the 3 dimensions for all of the patients (see table 2).Further information regarding the procedure and patient outcome was not provided.Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's electromagnetic system.There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.Reported accuracy discrepancy is noted but there is no allegation of inaccuracy.

Manufacturer Narrative

Correction to catalog number and device udi number now provided.Device manufacturing date now provided.

• 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: kristianna bilan ; 826 coal creek circle; louisville, CO 80027 ; 7208902338
• MDR Report Key: 6154659
• MDR Text Key: 61734012
• Report Number: 1723170-2016-05731
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450944
• UDI-Public: 00613994450944
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9733927
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/11/2016
• Initial Date FDA Received: 12/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2008
• 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): Life Threatening
• Patient Age: 29 YR