MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA II VALVE; SHUNT, CENTRAL NERVOUS SYSTEM

Model Number 42866

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

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 07/30/2018

Event Type  malfunction  

Event Description

Patient went to surgery to place a right-sided ventriculoperitoneal shunt with abdomen laparoscopic approach.Per the op note, the surgeon inserted a ventricular catheter into the right frontal horn at 7 cm; then, she hooked the valve to the ventricular catheter first, tied with 0 silk ties, and then tunneled the subcutaneous tissue down to the abdomen with the tunneler and then passed through the distal catheter without any complication.She connected the distal catheter to the distal end of the valve and tied with 0 silk.With pumping she was able to see clear cerebrospinal fluid (csf) coming from the ventricular catheter.She removed 20-25 ml of csf prior to closing.The valve was set at 1.5.The next day ct shows decrease in ventricle size, but still dilated with a pressure drop to 1.0.Follow-up on the subsequent day shows ct with mild interval decrease in lateral and third ventriculomegaly as well as mild decrease in subependymal csf migration.On (b)(6) 2018 ct shows there is interval increase in lateral and third ventriculomegaly with some visible hypodensity consistent with csf migration; suspicious for shunt malfunction.Md found the shunt valve compressible and refills easily; tap performed and removed 30 cc csf easily.The proximal function was determined to be good.Subsequently, shunt series (x-rays) done which showed no disconnection or migration.Patient to or for exploratory lap and shunt revision.Per op the outside of the ventricular catheter was intact.The medtronic valve and the distal catheter was carefully pulled out and all suture ties were cut.There was a very good csf flow from the ventricular catheter and with pressure there was good flow from the valve itself, but the valve was filled with blood mixed csf.This valve was removed and a new one placed.

• Brand Name: STRATA II VALVE
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona dr.; goleta CA 93117
• MDR Report Key: 7977031
• MDR Text Key: 124095970
• Report Number: 7977031
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 42866
• Device Catalogue Number: 42866
• Device Lot Number: E41892
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/11/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 17155 DA
• Patient Weight: 76