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 Hemorrhage, Intraventricular (1892); Unspecified Infection (1930); Therapeutic Response, Decreased (2271); Iatrogenic Source (2498)

Event Date 05/28/2016

Event Type  Injury  

Manufacturer Narrative

Patient specific ages were not provided; median age of this population was 51 (range 19¿89) years old.Therefore, 51 years was used.Patient sex not provided in the journal article; 29 patients were female and 22 were male, therefore female was used.Event date is approximated as the exact dates were not made available.The journal articles was made available online may 28, 2016, and therefore used as the event date.Citation: xu, l.W., sussman, e.S., & li, g.(2016).Clinical neurology and neurosurgery.Frameless, electromagnetic image-guided ventriculostomy for ventriculoperitoneal shunt and ommaya reservoir placement, 147, 46-52.Http://dx.Doi.Org/10.1016/j.Clineuro.2016.05.024.Brand name, common device name and procode not provided by the journal article authors.The article mentions a navigation system (model not specified).Further information unavailable.Those selected are suspected to be for the device used.510k not provided by the journal article authors.The selected is suspected to be for the device used.Multiple attempts have been made to obtain additional information.No additional information has been provided.No request for service have been received from the customer regarding these events.No parts have been replaced or returned to the manufacturer.Long-term post-operative complications occur frequently, and most commonly include catheter malfunction and/or infection and are known inherent risks of the procedure.Per the journal article, in conclusion, em image-guided ventriculostomy can be a safe and efficient way to ensure proper catheter placement and minimize patient complications.Larger prospective studies are warranted to further investigate the safety and superiority of this technique.Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation system.There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.

Event Description

Per the attached journal article, forwarded by a medtronic representative, the navigation system was used.A retrospectively review of one neurosurgeon¿s experience using electromagnetic (em) image-guidance for ventriculo-peritoneal shunting (vps) and ommaya reservoir placement from 2011 to 2015.A total of 51 patients were identified, twenty-four (24) patients received ommayas, while 27 received vps.The external cranial anatomy was registered using facial tracing, and the accuracy of the em image-guidance was verified using the navigation software.A ventricular catheter was then placed into the lateral ventricle using em image-guidance with a sterile navigational probe inside the catheter during placement.The tip of the catheter during entire duration of placement is followed through the navigational system.After the function of the shunt system was confirmed by manually pumping the valve and observing spontaneous flow in the abdominal cavity, the valve was placed into the subgaleal pocket and the cranial and abdominal incisions were closed.All catheters were successfully placed with one pass.In all cases, post-operative computed tomography (ct) confirmed that the catheter was in the desired location (fig.3).There was one case of post-operative, clinically silent, intraventricular hemorrhage noted on ct scan following vps placement, which was not clinically significant (fig.4).Post-operative infection occurred in one patient (2%).Four (4) patients required reoperation of the ommaya or vps (7.8%), 2 within the first 30 days (4%).Reasons for this reoperation included occipital horn trapping (1; fig.5), shunt erosion through skin in a patient who had psychiatric issues leading to wound picking (1), obstruction of ommaya reservoir (1; fig.6), and infection (1).Overall, less than 8% required revision with an average of 12 months of follow up after placement.The four cases requiring revision are discussed below.Only one patient required reoperation for obstruction or misplacement.This was an ommaya reservoir placed into the right frontal horn via a right-sided burrhole at kocher¿s point.Intraoperative image guidance revealed the catheter tip to be optimally located within the target ventricle.Additionally, the ommaya reservoir was checked for accurate positioning within the ventricular space by drawing back csf via the reservoir prior to skin closure using a 25-gauge needle on a syringe.Nonetheless, on post-operative day 2, csf could not be accessed via the reservoir, nor could the apparatus be flushed distally, suggesting a proximal catheter tip obstruction.Repeat imaging at that time revealed continued localization of the catheter tip within the target ventricle without any disconnection or migration.Consequently, the patient was taken back to the operating room for a replacement of the ommaya reservoir, after which post-operative imaging revealed similarly optimal placement within the target ventricle and the apparatus functioned adequately thereafter.Three other patients required revision for reasons not related to obstruction or misplacement.One patient developed a shunt infection and required externalization, one patient who continually picked at her wound due to psychiatric issues developed skin breakdown over the valve and required revision, and one patient developed an entrapped occipital horn 3 months after initial shunt placement and required revision.In the study, authors saw an even lower 30 day (4%) and one-year revision rate (7.8%), which is much lower than reported historical controls.Most likely causes of this improvement in shunt survival are more optimal catheter tip placement and reduction in number of passes needed, thus preventing unnecessary material that could clog the tip upon each pass.No further details were provided.Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic's navigation system.There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.

• 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: oksana ditolla ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 6577069
• MDR Text Key: 75502603
• Report Number: 1723170-2017-02056
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• 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?: No
• Date Manufacturer Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2011
• 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: 51 YR