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

Model Number UNKNOWN-S

Device Problems Complete Blockage (1094); Disconnection (1171); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 03/10/2023

Event Type  Injury  

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

Danielle s.Wendling-keim.The survival time of the ventriculo-peritoneal-shunt in children with hydrocephalus is dependent on the type of valve implanted.(2023) 39:119.Https://doi.Org/10.1007 /s00383-023-05395-0 abstract purpose despite constantly improving developments in ventriculo-peritoneal shunt systems, most patients with hydrocephalus require revision or replacement at some point of time.Therefore, this study aimed to analyse parameters that are associated with shunt dysfunction.Methods in this retrospective study, we included 81 patients aged 0-17 who were treated at our institution.Demographic data, etiology of the hydrocephalus, type of valve implanted, reason for any revision procedures, any complications and survival time of the ventriculo-peritoneal shunts were detected.Statistical analysis was performed using spss.The significance level was set at p.::; 0.05.Results over a mean study period of 18 years, we analyzed 226 valves subjected to 146 revision operations in 81 patients.The etiology of the hydrocephalus (p = 0.874) and the age of the child at the time of vp shunt implantation (p = 0.308) did not have any impact on the shunt survival time.However, the type of the valve significantly changed the survival time of the shunt (p = 0.030).Pressure differential valves presented a longer survival time than gravitational valves.Conclusion the majority of patients in this study needed at least one replacement of the initial shunt system.Pressure differential valves may be beneficial for the survival time of the shunt system.Events: there were a total of 65 patients implanted with a medtronic valve.The causes of shunt failures were as follows.24 valve dysfunctions, 2 infections, 5 central disconnections, 15 peripheral disconnections, and 5 obstructions.

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®
• 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: 16656257
• MDR Text Key: 312434560
• Report Number: 9612501-2023-00556
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• 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: 04/03/2023
• 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