MAUDE Adverse Event Report: COVIDIEN LLC STRATA II VALVE, REGULAR; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 42866

Device Problems Complete Blockage (1094); Infusion or Flow Problem (2964)

Patient Problems Intracranial Hemorrhage (1891); Coma (2417)

Event Date 12/22/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that before the shunt, the patient had an operation to remove a brain tumor (pilocytic astrocytoma), and an external lateral ventricular drain (evd) was placed on the right on (b)(6) 2020.On (b)(6) 2020, the drainage system was removed due to ventricular bleeding.Over the next 24 days, cerebrospinal fluid (csf) was repaired.There were no signs of infection in the csf during the whole period, and the patient received antibiotic-prophylactic.On (b)(6) 2020 the patient was implanted with a ventriculoperitoneal shunt without any complication.The valve performance was set at 2.The next day, the healthcare professionals (hcp) noticed signs of shunt insufficiency.The patient was experiencing drowsiness, and rising sun sign.Ct of the head showed a typical placement of ventricular catheter in the lateral ventricle with no signs of bleeding.The valve performance was reduced to 1 and then to 0.5, but due to the lack of positive development, on (b)(6) 2020, a shunt revision was performed where a blockage with blood particles of the ventricular catheter was observed.It was stated that this was cleared up.After the operation, the hcp observed no positive development so a double shunt revision was fulfilled.As a result of the revision, it was found that the peritoneal and ventricular catheters were open.At that time, it was assumed that the shunt peritoneal catheter made a hook in the tunnel in which was corrected by stretching during the placement back of the catheter.Several hours later after the operation, signs of tentorium occlusion developed mostly on the left side (coma, expressed rising sun sign, 6th nerve function insufficiency).The valve performance was checked which was the same at 0.5.Urgently, on (b)(6) 2020, an evd was placed on the left side.The shunt system has not been removed.Treatment has continued in the icu.The patient's condition has been assessed as severe during the last 2 weeks.Until (b)(6) 2021, the patient was on respiration with a low level of consciousness (coma, then sopor).The external drainage reservoir was located 10-12 cm above the external auditory canal; however, daily 400-450 ml accumulated in the reservoir.Positive dynamics was noticeable in the last 3 days.The patient opened their eyes, moved limbs, and followed some instructions.On (b)(6) 2021, an mri examination of the head was performed, and the results showed decreased ventriculomegaly, lack of continuous tumor growth but signs of hemorrhage on the left side of the midbrain as a result of the tentorium occlusion.Consultation with the neurosurgeons came to the conclusion that there was a problem with the valve.

Event Description

Additional information received reported that the peritoneal and the ventricular catheters were from another manufacturer that was compatible with the valve.It was stated that 2 shunt revisions were made, and during the second revision, they excluded blockage of the catheters as well as blockage of the valve.Since the valve settings were on the lowest setting (0.5), no actions were taken to change anything with the valve.A new evd was implanted into the patient in another ventricle to solve their hydrocephalus and save their life.It was noted that the by the impression of the doctors, the valve was functioning but not enough in correspondence to it's setting of 0.5.The shunt system was explanted on (b)(6) 2021.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STRATA II VALVE, REGULAR
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• MDR Report Key: 11178123
• MDR Text Key: 227055598
• Report Number: 9612501-2021-00085
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00763000027261
• UDI-Public: 00763000027261
• Combination Product (y/n): N
• PMA/PMN Number: K042465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2022
• Device Model Number: 42866
• Device Catalogue Number: 42866
• Device Lot Number: 0217254781
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/11/2021
• Initial Date FDA Received: 01/15/2021
• Supplement Dates Manufacturer Received: 01/19/2021
• Supplement Dates FDA Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 16 YR
• Patient Weight: 56