MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA II VALVE, REGULAR, WITH BIOGLIDE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 92866

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/09/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported the ventriculoperitoneal shunt procedure was performed by dorsal horn puncture by the physician, and the flow was checked during the operation.In order to check the valve function during the postoperative process, pumping of the reservoir was performed, and reservoir remained recessed.A revision was performed with suspicion of a ventral obstruction.Aneurysms had been performed multiple times, and the protein concentration seemed to be high.The contrast agent flow from the reservoir but remained stagnant near the neck.However, it was unknown whether the contrast agent flowed little by little, it could be confirmed intermittently on the ventral side by x-ray.

Manufacturer Narrative

The returned valve was attached to the catheter from pe 703265715-10.The valve met the requirements for the patency, valve flux, leak, reflux, siphon, pressure-flow, and preimplantation testing.Therefore, the nature of the complaint could not be duplicated by laboratory personnel.The valve was returned with a performance level between 2.5 and 0.5.The laboratory personnel were able to adjust the setting to 0.5 and then to each performance level setting on the first attempt.There was proteinaceous debris on the interior and exterior of the valve.The instructions for use cautions, ¿the system may become occluded internally due to tissue fragments, blood clots, tumor cell aggregates, bacterial colonization or other debris.¿ base misalignment was observed in the reservoir of the device.It is unknown how or when this damage occurred.The instructions for use cautions, ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting or crushing of components.Such damage may lead to los of shunt integrity¿¿ all valves are 100% tested at the time of manufacture.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.

Manufacturer Narrative

Evaluation result and conclusion code corrected.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, WITH BIOGLIDE
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8846451
• MDR Text Key: 152801318
• Report Number: 2021898-2019-00302
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K042465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/10/2019

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 Model Number: 92866
• Device Catalogue Number: 92866
• Device Lot Number: E46113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2019
• Initial Date Manufacturer Received: 07/17/2019
• Initial Date FDA Received: 07/31/2019
• Supplement Dates Manufacturer Received: 08/21/2019; 08/21/2019
• Supplement Dates FDA Received: 09/10/2019; 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention