MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC MEDTRONIC NAVIGATION; INSTRUMENT, STEREOTAXIC

Model Number UNK_NAV_SYS

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

Patient Problems Hemorrhage, Intraventricular (1892); Neurological Deficit/Dysfunction (1982)

Event Date 02/01/2019

Event Type  Injury  

Manufacturer Narrative

Age or date of birth: the patient age is the average age of the 25 patients.Sex: there were 11 male patients and 14 female patients.Weight: patient weight not available from the site.Date of event: event date is approximated as it was reported that the surgeries were completed between (b)(6) 2010 and (b)(6) 2015.Lot #, serial #: device lot number, or serial number, unavailable.Udi #: udi not available for this system at time of filing.Device evaluated by mfr: the device was not returned, so no analysis was conducted.If information is provided in the future, a supplemental report will be issued.

Event Description

Citation: world neurosurg.(2019) 122: e723-e728.Background: placement of intraventricular catheters in oncology patients is associated with high complication rates.Placing ommaya reservoirs with the zero-error precision protocol (zepp), a combination of neuronavigation (axiem stereotactic navigation) and direct verification of catheter tip placement with a flexible neuroendoscope,is associated with decreased complication rates as a result of increased catheter placement accuracy.However, the zepp costs more than traditional methods of catheter placement, and the question of whether this increased accuracy with the zepp is cost-effective is unknown.Methods: we performed a single-center retrospective chart review of 50 consecutive ommaya reservoir patient placements between 2010 and 2017.Twenty-five ventricular catheters were placed using the zepp protocol, and 25 ventricular catheters were placed using only axiem stealth navigation.Postoperative catheter accuracy and complication rates were assessed.A cost-benefit analysis was then conducted to determine if the overall cost for placing ommaya reservoirs with the zepp was effective compared with the alternative method of using neuronavigation alone.Results: in the non-zepp cohort, 10 of 25 catheters were placed within the optimal location compared with 25 of 25 catheters placed in the zepp cohort.Three complications occurred in the non-zepp cohort: 2 malpositioned catheters required surgical revision and 1 catheter-related hemorrhage resulted in a prolonged stay in the intensive care unit.No complications occurred in the zepp cohort.A cost-benefit analysis showed $4784 savings per patient with zepp utilization because of the high complication associated costs.Conclusions: implementation of the zepp for verifying ventricular catheter placement in ommaya reservoirs improved catheter tip accuracy, resulted in lower complication rates, and was more cost-effective when compared with the non-zepp cohort, which used only neuronavigation.The zepp can be used for ventricular shunt catheter placement to decrease complications and verify catheter tip accuracy in ommaya or standard ventriculoperitoneal shunts.Adverse events: the non-zepp group had a 40% success rate for optimal catheter localization (10/25).The non-zepp group also had a 12% complication rate (3/25).One patient suffered an intraventricular hemorrhage with neurologic deficit from multiple ventricular catheter passes that were done without neuroendoscopy before finally encountering csf.2 other patients had parenchymal catheter tip location, necessitating a return to the operating room for surgical revision.

Manufacturer Narrative

Additional review of the reported issue found that the reported literature file was previously reported under mdr 17 23170-2019-02262.Please refer to 1723170-2019-02262 in regards to the reported event.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MEDTRONIC NAVIGATION
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8641093
• MDR Text Key: 146087838
• Report Number: 1723170-2019-02632
• 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: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK_NAV_SYS
• Device Catalogue Number: UNK_NAV_SYS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR