MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROSA VALVE; HYDROCEPHALUS VALVES

Model Number FV701T

Device Problem Infusion or Flow Problem (2964)

Patient Problem Hydrocephalus (3272)

Event Date 08/11/2017

Event Type  Injury  

Manufacturer Narrative

This complaint was reopened in reference to (b)(4).Investigation: visual inspection scratches and a deformation of the outer housing of the progav® valve was observed throughout the visual inspection.The measurement of the plane parallelism could confirm that with a value of -0,094mm the housing membrane is clearly outside tolerance (0 ± 0.02 mm).Significant outside pressure, for example by too much force from the prosa® adjustment tool or by a fall or impact to the head of the patient, can compromise the integrity of the valve.Permeability test a permeability test has indicated that the valve has a blockage.Adjustment test the prosa® valve was tested and is adjustable to all specified pressures.Braking force and brake function test: the brake functionality test has shown that the brake function is fully operational and the braking force is within the given tolerances.Computer controlled test: to investigate the claim of under-drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.Because the valve is not permeable, a computer controlled test is not possible.Results: first, we performed a visual inspection of the valve.Scratches and a deformation of the outer housing of the prosa® valve were observed through the visual inspection.This deformation was confirmed through a measurement of the plane parallelism.Significant outside pressure, for example by too much force from the prosa® adjustment tool or by a fall or impact to the head of the patient, can compromise the integrity of the valve.The exact cause of the deformation of the prosa® valve could not be determined throughout our investigation.Next, we tested the permeability, adjustability, as well as the brake functionality and brake force.The valve was not permeable.Due to the non-permeability of the valve, a computer controlled test was not possible to further investigate the clinical claim of under-drainage.The valve is adjustable to all specified settings, the break is fully functional and the brake force is within given tolerances.Finally, we have dismantled the valve.Inside the valve we have found a build-up of substances (likely protein).Based on our investigation, we confirm the presence of deposits in the valve, which could have caused malfunction in the past.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hg-therapy by shunt implants.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miethke (b)(4) no further regulatory actions are required from our point of view.

Event Description

It was reported that a prosa valve.(#fv701t) was implanted during the procedure on (b)(6)2016.According to the complainant, the valve was believed to be not adjustable.The patient underwent a revision procedure on (b)(6) 2017.The complainant device was returned to the manufacturer for evaluation.Height: 70cm.

• Brand Name: PROSA VALVE
• Type of Device: HYDROCEPHALUS VALVES
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12968505
• MDR Text Key: 286431493
• Report Number: 3004721439-2021-00810
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 04041906133023
• UDI-Public: 4041906133023
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K120559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/09/2021

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 Expiration Date: 12/31/2020
• Device Model Number: FV701T
• Device Catalogue Number: FV701T
• Device Lot Number: 20031268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2017
• Initial Date FDA Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2016
• 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
• Patient Age: 17 MO
• Patient Weight: 11 KG