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

Model Number 42866

Device Problem Insufficient Information (3190)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/20/2021

Event Type  Death  

Manufacturer Narrative

Foreign report source: this event occurred in (b)(6).No products have been returned to medtronic for analysis.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding valves.It was reported that the patient used two pressure-adjustable valves at the same time, both of which could not work after installation.According to clinical analysis, the two valves interfered with each other and could not work, which resulted in the increase of the patient's pupil.This was noted to be the cause of the patient's death.Intervention was performed by the way of external drainage.There was no reported delay to the procedure.Additional information was received.It was reported that the clinical suspicion was that the reason was that there was interference when two identical valves are used at the same time, causing the two shunt valves to not work when implanted in the body.It is clinically recognized that the death was caused by the failure of the medtronic product to work.It was also indicated that the cause of death was not determined, which contradicts what was previously reported.The patient's death was observed during postoperative observation, but the specific time point was uncertain.The patient passed away at a medical facility.A toxicology report is unavailable.

Event Description

Additional information was received.It was reported that it was clinically believed that there was interference when the two products of our company were used at the same time.As a result, the product did not work and eventually the patient died.It was noted that the cause of death was in the opinion of clinician, and there was no definite evidence.

Manufacturer Narrative

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

Manufacturer Narrative

H2) additional information was added to the event description.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

The reported cause of the death is unknown.At the time of implantation, no distal valve or shunt flow was observed.The valves were located on both sides of the head.The valve will not be returned for analysis.The reason was that the product was in the body of the deceased and could not be taken out.

• 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: 14086841
• MDR Text Key: 289096814
• Report Number: 9612501-2022-00550
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00763000027261
• UDI-Public: 00763000027261
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K042465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 42866
• Device Catalogue Number: 42866
• Device Lot Number: 0222372739
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/18/2021
• 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): Death
• Patient Age: 15 YR
• Patient Sex: Male