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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number S7
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Brain Injury (2219); Iatrogenic Source (2498)
Event Date 02/10/2015
Event Type  Injury  
Manufacturer Narrative
A cross-functional team review of the journal article confirmed there is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event. Multiple system checkouts have been completed on this system since the event date.
 
Manufacturer Narrative
Specific patient identifier not available from the journal article authors. This patient was labeled as case no. 4 and therefore used. Patient weight not available from the journal article authors. Event date is approximated. The date provided was the date of online publication. Citation: hermann, ej. , petrakakis, i. , götz, f. , lütjens, g. , lang, j. , nakamura, m. , & krauss, jk. Surgical treatment of distal anterior cerebral artery aneurysms aided by electromagnetic navigation ct angiography. Neurosurg rev (2015) 38:523¿530. Doi 10. 1007/s10143-015-0611-9 per the journal article, treatment is challenging both with surgical and endovascular approaches even in unruptured aneurysms because of their usually small size, distal location, and adherence to the frontal lobes inside the narrow interhemispheric fissure. One particular challenge in operating these deep-seated aneurysms is to select a convenient surgical approach and to localize the aneurysm promptly with adequate proximal control of the supplying vessel. Multiple attempts have been made to obtain additional information. No further information provided in the journal article or from the authors. 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 em navigation system. There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.
 
Event Description
It was reported that the electromagnetic (em) navigation system was used. This is mdr report three of three. This study aimed to investigate feasibility, safety, accuracy, and usefulness of electromagnetic (em) navigation to aid clipping of distal anterior cerebral artery (daca) aneurysms. The authors prospectively collected data from eight patients who underwent ct angiography-guided em navigation for surgery of daca aneurysms between october 2008 and april 2013. For em navigation, the neuronavigation system was used. While the authors used fiducials fixed to the osseous skull in earlier studies, they have modified their technique thereafter by surface-rendering of the face. Preoperatively, cranial ct was performed. For preoperative 3d-reconstruction, a medtronic planning/workstation was used. The dynamic reference frame (drf) was attached to the patient¿s head fixed by adhesive tape just above the mastoid process. Intraoperative registration was achieved by surface matching over the facial surface bilaterally in supine position. Confirmation of accuracy was achieved. After craniotomy was performed and before opening of the dura, the authors used the em navigation pointer with the virtual tip extension to obtain precise orientation with regard to the direction and the distance to the aneurysm. Then, after microsurgical opening of the dura and cerebrospinal fluid (csf) release, the em pointer was used again for orientation. Here, additional care was taken not to blindly rely on the navigation because of possible brainshift especially in patients with ruptured aneurysms and brain swelling. Thereafter, the operation was continued in standard microneurosurgical technique following the trajectory to the target point. Subsequently, the surgeon alternated various times from microsurgical preparation under microscopical view to on-line tracking navigation via the tip of the em pointer to check the distance and control the right direction to the target. Once reaching the aneurysm by microscopical view, they checked again accuracy by direct positioning of the tip of the em pointer on the aneurysm and comparing its position with the 3d-ct angiography data set on the navigation screen. Postoperative ct scans were obtained 6 hours after surgery to rule out any postoperative complications like bleeding, infarction, brain swelling, hydrocephalus, or pneumocephalus. A postoperative digital subtraction angiography (dsa) was performed to control and document occlusion of the clipped aneurysm and to rule out additional aneurysms within 7 days postoperatively. Fast and accurate referencing was possible in all patients. Accuracy of registration was within 2 mm in any case in all three axes as determined by checking the positions for tragus, nasion, and bregma. A (b)(6) woman with a ruptured 4 mm bifurcation aneurysm (pericallosal/callosomarginal) was selected for urgent em-guided surgery based on ct angiography. Preoperative ct of the head showed a subarachnoid hemorrhage in the frontal interhemispheric fissure without intracerebral or intraventricular hematoma. After referencing the patient in supine position with the head fixed in the mayfield clamp first, an external ventricular drainage on the right side was inserted via kocher¿s point using the em-navigation stylet without csf release. A tailored craniotomy and the optimal trajectory to the aneurysm were planned on the navigation screen using the tip extension view after clipping of the aneurysm, icg angiography was performed to confirm occlusion of the aneurysm and patency of the parent vessel distal and proximal to the clipped aneurysm. Postoperative ct control 6 hours after clipping showed no infarction and postoperative transfemoral dsa reconfirmed complete occlusion of the aneurysm. Em-guided neuronavigation using ct angiography for daca aneurysms enabled fast and accurate referencing of the patient and planning of a tailored craniotomy without opening of the frontal sinus. Intraoperative accuracy was highly reliable except in one instance due to dislocation of the dynamic reference frame (drf). Em navigation allowed a straightforward approach through the interhemispheric fissure even in patients with subarachnoid hemorrhage with swollen brain tissue and blood constraining the view of the surgeon. Flexible em navigation with a drf appears to be a very useful method in planning the tailored craniotomy and the optimal trajectory to the daca aneurysms because even changes of the head position after referencing of the patient in the mayfield clamp to optimize head angulation for surgery is possible and useful without loss of navigation accuracy. Em navigation is clearly advantageous for this purpose since surgical time was shorter, and there are no line-of-sight problems and better comfort was provided to the surgeon after re-angulation of the patient¿s head to determine the most appropriate trajectory after registration. Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic em navigation system. There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.
 
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Brand NameSTEALTHSTATION S7 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
oksana ditolla
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
MDR Report Key6598424
MDR Text Key102389171
Report Number1723170-2017-02206
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 07/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberS7
Device Catalogue Number9733858
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/21/2011
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: 05/30/2017 Patient Sequence Number: 1
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