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 Death (1802); Brain Injury (2219); Blood Loss (2597)

Event Date 08/23/2017

Event Type  Death  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.

Event Description

A medtronic representative reported that, while in a transsphenoidal tumor resection, the surgeon made contact with the interior carotid artery which led to a bleed.A non-navigated ring curette was in use when attempting to extract tissue from the patient.Following the bleed, the representative reported that the patient was stabilized and transferred to an endo surgery.During the endo procedure, it was found that the vessel had detached and was sacrificed.The site then placed the patient on life support and expired at a later date.No allegation of deficiency was made against a medtronic product as a non-navigated instrument was in use.The surgeon reported that the tumor was surrounding the artery which led to a known risk of the procedure.There was no reported delay to the procedure due to this issue.No additional information was provided.

Manufacturer Narrative

The logs for the navigation system were reviewed by medtronic personnel.However, the logs provided no additional insight into the probable cause of the anomaly.The archive used in the procedure was evaluated by medtronic personnel.The evaluation found that one computed tomography (ct) had been imported and contained 1mm contiguous slices, though the registration performed was not saved to the archive.

Manufacturer Narrative

A medical safety assessment was completed for the reported event, that used the navigation system and navigation instruments (including a non-invasive patient tracker, disposable tracker, and a malleable suction).Per the instructions for use for the non-invasive patient tracker, ¿potential adverse events associated with neurological procedures, though not necessarily associated with use of this device, include but are not limited to: device malfunction, subdural fluid collection, hemorrhage, hematoma with neurological compromise, development of abdominal pseudocyst, seizure, brain swelling, infarction, disturbance of consciousness, motor deterioration, hemiparesis, aphasia, or other neurologic deficit.¿ operating room records were reviewed but provided no additional information.It is stated that during an additional surgery, no navigation was used, they found the vessel had detached.The patient was put on life support and died a few days after.It was also noted that the surgeon stated the adverse event ¿was not related to navigation, as the tumor was surrounding the artery.¿.

• 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: stephanie riley ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 6884504
• MDR Text Key: 86975694
• Report Number: 1723170-2017-03836
• 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,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2013
• 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): Death; Hospitalization
• Patient Age: 67 YR
• Patient Weight: 80