MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATAMR VALVE, SMALL; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number 42955

Device Problems Inaccurate Flow Rate (1249); Appropriate Term/Code Not Available (3191)

Patient Problems Headache (1880); Vomiting (2144); Therapeutic Response, Decreased (2271); Lethargy (2560)

Event Date 01/05/2017

Event Type  Injury  

Manufacturer Narrative

The returned valve was patent.Therefore the conditions of the complaint could not be duplicated by laboratory personal.The valve met the requirements for siphon, reflux, and pre-implantation testing.However, the valve did not meet the requirements for pressure-flow and leak testing due to a tear in the top of the reservoir.It is unknown how or when this damage occurred.The instructions for use (ifu) caution that ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting, or crushing of components.¿ the ifu also caution that ¿care should be taken in handling the valves as silicone has a low cut and tear resistance.A review of the manufacturing records showed no anomalies.All valves are 100% tested at the time of manufacture.

Event Description

It was reported to medtronic neurosurgery that the device had been implanted for 6 weeks and there was no flow.According to the report, the patient underwent ct imaging, but no mris were done.The ct imaging reportedly showed an enlargement of the patient¿s ventricles.The device was then explanted and upon inspection, there was no internal debris.Reportedly, there was significant resistance to flow when tested off the table, even with moderately applied syringe pressure.It was stated the patient went home following the procedure and there were no issues.

Manufacturer Narrative

Additional information received reported the valve was primed with a solution of bacitracin and saline at implant.Event and explant dates updated.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

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

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.

Event Description

Additional information received reported that by november 29, 2016, their shunt was appearing to malfunction, and a shunt tap was ordered.There was spontaneous flow, not under significant pressure.Aspiration of 3 ml of clear cerebrospinal fluid was removed.On (b)(6), 2017, the patient was in the emergency room with a history of 12 hours of headache and recurrent vomiting.On examination, the patient was noted to be awake, alert, and interactive but visibly uncomfortable with a heart rate in the 50s.A ct scan reveal enlargement of the bilateral ventricluar system with unchanged positioning of the left parietal approach ventricular catheter.Aspiration of their left parietal approach ventriculoperitoneal shunt revealed clear cerebrospinal fluid with spontaneous flow under moderate pressure, 10 ml of which were removed.The doctor believed there was a shunt malfunction due to the patient's clinical signs and symptoms including headache, emesis, and lethargy.On (b)(6), 2017, their shunt was revised.During the procedure, the doctor disconnected the ventricular catheter from the valve and found that the catheter drained spontaneously clear cerebrospinal fluid under a significant amount of pressure.They then proceeded to connect the manometer to the proximal end of the valve using a small piece of tubing and found no evidence of spontaneous flow through the valve and peritoneal catheter.The doctor tried to gently flush into the valve and again found no evidence of flow through the manometer system into the valve and peritoneal catheter.They removed the existing valve and connected the manometer to the peritoneal catheter itself.The sterile saline then flowed into the peritoneum briskly and spontaneously to a level of -3 cm of water consistent with a patent peritoneal catheter system and confirming the diagnosis of a valve malfunction.After the valve was removed on a side table, the doctor attempted to flush through the valve and met significant resistance with an inability to push fluid through the valve itself.

• Brand Name: STRATAMR VALVE, SMALL
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6299025
• MDR Text Key: 66427383
• Report Number: 2021898-2017-00041
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00643169692718
• UDI-Public: 00643169692718
• Combination Product (y/n): N
• PMA/PMN Number: K152700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 42955
• Device Lot Number: E12556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2017
• Date Manufacturer Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1702-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 12 YR