MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) SYS CART TREON VIEW 220V PLS; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number TREON

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

Patient Problems Infarction, Cerebral (1771); Unspecified Infection (1930); Iatrogenic Source (2498)

Event Date 08/31/2014

Event Type  Injury  

Manufacturer Narrative

Patient specific ages were not provided; mean age of 45 years (range 12-73 years) and therefore used.Five females and 7 males participated in the study; therefore males was used.Event date is approximated as the exact dates were not made available.Date selected since study was through (b)(6) 2014.Citation: fischer, g., senger, s., sharif, s., & oertel, j.Gerrit fischer, sebastian senger, salman sharif, & joachim oertel.Superficial temporal artery to middle cerebral artery bypass via a minimized approach: operative nuances and problem-solving aspects.World neurosurg.(2016) 88:97-103.Http://dx.Doi.Org/10.1016/j.Wneu.2015.12.029 brand name, common device name and procode not provided in journal article.The article mentions a navigation system (model not specified).Further information unavailable.Those selected are suspected to be for the device used.Device serial number was unavailable.The selected is suspected to be for the device used.The selected is suspected to be for the device used.Per the article, neuronavigation based on ct angiography data has proven to be a reliable vessel preselection and detection tool and potentially facilitates and accelerates the identification of the sta branch compared with palpation or a doppler probe.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 navigation 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.It was reported that the navigation system was used.Between february 2011 and august 2014, seventeen superficial temporal to middle cerebral artery (stamca) minimally invasive bypass procedures were performed on 12 patients.Five females and 7 males with a mean age of 45 years (range 12-73 years).Using neuronavigation, the course of the selected sta branch is marked on the skin for intended 2-2.5 cm craniotomy.Skin incision is performed under microscopic view directly on the selected sta branch.The vessel is harvested under microscopic view.After splitting the temporalis muscle, a burr hole is made with a high-speed drill as a starting point for a small osteoplastic craniotomy.The neuronavigation was applied without any difficulties in all 17 cases.After removal of the temporary clips, flow is ensured by indocyanine green videoangiography and micro doppler in each case.Periprocedural complications like epidural or subdural hematoma, cerebrospinal fluid leakage, and seizures were not observed.One patient harbored a local ischemic event (small infarction) on the fourth day postoperatively.Another patient presented wound infection due to extensive scarring after multiple burr-hole therapy several years ago.All other postoperative courses remained uneventful.Within the hospital stay, all anastomoses were patent as shown by angio-ct and duplex sonography.All bypasses remained open on duplex sonography follow-up performed every 6 months.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.

Manufacturer Narrative

Device product part number, brand name, catalog number and device manufacturing date now provided.Those selected are suspected to be for the device used as the journal article author's did not provide this information.

Manufacturer Narrative

Additional investigation and journal article review was conducted.It was confirmed there is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.A system checkout have been completed on this suspected system since the event date per system history and confirmed the system performed as intended.

• Brand Name: SYS CART TREON VIEW 220V PLS
• 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: 6600173
• MDR Text Key: 76236326
• Report Number: 1723170-2017-02243
• Device Sequence Number: 1
• Product Code: HAW
• 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,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 08/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• 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: 9730749
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2004
• 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; Other; Required Intervention
• Patient Age: 45 YR