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

Model Number UNKNOWN-S

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 02/03/2023

Event Type  malfunction  

Manufacturer Narrative

No parts have been returned for analysis 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.

Event Description

Segev gabay, md, ventriculosinus shunts: their role in selected patients, journal of nerosurgery, pg 1-7, 16 dec 2022 https://doi.Or g/10.3171/2022.11.Peds22406.Objective ventriculoperitoneal shunt placement is the most common treatment for hydrocephalus.However, most patients will require multiple shunt revisions over time.In cases of peritoneal shunt failure, the pleura and heart are alternative distal sites.Sinus shunts have been described but are not commonly used.The potential vascular complications, as well as inexperience with these shunts, make these tools less attractive.The goal of this study was to share the authors¿ experience with ventriculosinus shunts (vsss) in selected patients.Methods between december 2018 and february 2022, a total of 7 patients (1 adult, 6 children) underwent 11 surgeries for the placement of a vss at the authors¿ institution.Data regarding complications and shunt function were retrospectively collected and assessed, and a review of the literature was conducted.Results the mean (± standard deviation) age at surgery was 11.9 ± 12.8 years (range 1.3¿38.2 years).All patients had previous shunt systems that failed and systemic conditions that made other distal sites less desirable.In all cases, a low-pressure differential valve was installed.Over a mean follow-up of 18 ± 9.8 months (range 9¿39 months), 4 of the 7 patients underwent additional shunt revisions, 2 of whom had shunts placed at other sites.One patient had symptomatic partial sinus thrombosis, managed conservatively.During follow-up, 5 patients showed improvement in their symptoms of high intracranial pressure using the vss.There were no severe complications of air embolism, bleeding, or infection.Conclusions vsss may have a role to play in selected patients in whom more commonly used distal shunt locations have failed.Significant complications with these shunts are rare.Additional experience is needed to better understand the ideal catheter and placement locations the follow-up period was 9¿39 months (mean 18 ± 9.8 months).Four of the 7 patients underwent additional shunt revisions: 2 (cases 1 and 3) had a distal vss revision, and 2 (cases 4 and 6) had shunts placed at other sites (heart and pleura; table 4).One patient (case 4) had symptomatic partial sinus thrombosis (fig.2) that was suspected given continued high icp symptoms, including drowsiness, vomiting, anisocoria, and bradycardia, all of which temporarily resolved with repeated shunt taps.It was confirmed on ctv performed for a shunt failure investigation.This was initially managed by revision of the distal catheter to the sinus; however, because of the continuation of symptoms, the vss was converted to a ventriculoatrial shunt.The remaining 5 patients with vsss (cases 1¿3, 5, and 7) showed immediate and continued improvement in their symptoms of high icp, and none of these patients had other shunt-related surgery.There were no other shunt-related complications.

Manufacturer Narrative

H10) correction to included literature article 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®
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• Manufacturer (Section G): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 16438803
• MDR Text Key: 310251161
• Report Number: 9612501-2023-00331
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: UNKNOWN-S
• Device Catalogue Number: UNKNOWN-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 12 YR