MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA INTEGRA FLOW REGULATING VALVE, LOW FLOW

Catalog Number XXX- LOW FLOW

Device Problem Infusion or Flow Problem (2964)

Patient Problems Unspecified Infection (1930); Tinnitus (2103)

Event Type  Injury  

Manufacturer Narrative

The device is not expected to be returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.The online version of the article can be found at: https://doi.Org/10.1016/j.Clineuro.2018.07.017.

Event Description

This is 2 of 2 reports.Other mfg report number: 9612007-2018-00022.Clinical neurology and neurosurgery (2018) published; ¿minimizing overdrainage with flow-regulated valves ¿ initial results of a prospective study on idiopathic normal pressure hydrocephalus¿ (inph).The objective of the article was to present the treatment results of patients treated with flow- regulated valves.The short- and midterm neurological outcome and report on overdrainage and complication rates were analyzed.From july 2013 to december 2017, thirty-two patients with inph treated with the integra nph low flow valve were prospectively enrolled.Clinical evaluation was performed at baseline, postoperatively as well as 3 and 6 months after surgery.The outcome was assessed by employing the inph grading scale and the mini mental status examination (mmse).Overdrainage was assessed clinically and radiologically by computed tomography.Patients characteristics: 11 females and 21 males.Age range 55-84.All patients presented with gait disturbance, 29 patients experiences cognitive impairment and 25 presented with urinary incontinence.Complications: one patient developed both-sided subdural hygromas 6 months after shunt implantation.The patient complained about tinnitus and the cranial ct scan showed slightly narrowed ventricles indicating overdrainage.Since there are no adjustment options of the flow-regulated valve, the hygromas were eventually evacuated via subdural drain and the integra low flow valve was exchanged to an adjustable sophy mini sm8 valve (sophysa).In another patient, the presenting symptoms of the patient initially improved after implantation of the flow-regulated valve and subsequently became worse again.Assuming there was a valve malfunction, the valve was exchanged for a sophy mini sm8 valve (sophysa).Following revision surgery, the symptoms improved again.One patient developed a shunt infection one month after shunt implantation that required shunt removal and antibiotic therapy via an external ventricular drain.Results: at 3-month follow-up, 25/31 patients (80.6%) improved on the total inph score by at least 5 points.The mean mmse score increased from 24.5 to 26.1 points.After 6 months, the improvement rates of the inph (82.1%) and the mmse scores (26.8 points) were stable.Conclusion: this prospective study suggests that the use of flow-regulated valves can lead to neurological improvement in shunted inph patients with a low risk of overdrainage.Moreover, the handling of these valve types is uncomplicated, since verification of the valve settings after mri and frequent reprogramming become indispensable.Further studies with a prospective design and long-term follow-up results will be necessary to draw a definite conclusion for flow-regulated valves and to establish a standardized clinical follow-up protocol.

Manufacturer Narrative

No product is available for investigation; no traceability information is available.The exact root cause of these events could not be determined based on the available information.

• Brand Name: INTEGRA FLOW REGULATING VALVE, LOW FLOW
• Type of Device: FLOW REGULATING VALVE, LOW FLOW
• Manufacturer (Section D): INTEGRA NEUROSCICENCS IMPLANTS SA; 2905 route des dolines; 2905 route des dolines; sophia antipolis F-069 21; FR F-06921
• MDR Report Key: 7833785
• MDR Text Key: 118870894
• Report Number: 9612007-2018-00025
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K140722
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX- LOW FLOW
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1