MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYST.PED.W/SA 20 A.PRECHAMBER; HYDROCEPHALUS VALVES

Model Number	FV441T-J
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	06/05/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a progav syst.Ped.W/sa 20 a.Prechamber.(#fv441t-j) was implanted during a procedure performed on (b)(6) 2017.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.
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: optical inspection: first step of our investigation is the optical inspection.Apart from slight scratches, we could not detect any obvious deformations or other abnormalities on the progav valve.Nevertheless, a value of -0.0520mm could be measured during the measurement of plan parallelism.Therefore, the valve is clearly out of the accepted tolerance (acc.Tolerance ± 0,02mm), even if no obvious deformation was apparent.Permeability test: to proof the penetrability we carried out a permeability test.This test was carried out at a hydrostatic pressure difference of approx.20-30 cmh2o in the flow direction.The investigation has shown that the progav valve was permeable.Adjustment test: our adjustment tests are carried out with the standard progav checkmate and measurement tool.The valve is adjusted from 0 up to 20 cmh2o and down again in the same way in steps of 5 cmh2o.The investigation has shown that it was not possible to adjust the valve.Braking force and brake function test: to measure the braking force we have investigated the valve with a braking force apparatus.Here, it is measured how much force must be exerted on the housing of the progav valve to release the rotor to adjust the valve by the integrated magnet of the braking force apparatus.The brake function test has resulted that the brake function is full in place.However, the braking force could not be measured because the valve can not be adjusted.Result: first we performed a visual inspection on the progav valve.Apart from slight scratches, we could not detect any deformations or other abnormalities.Nevertheless, the measurement of the parallelism has shown a deformation of the housing membrane.Since a deformation can impair the functionality of the brake function and also the adjustability of the valve, we have made an adjustment test on the valve.It was not possible to adjust the valve.Despite the deformation the braking function is given.However, the braking force could not be measured because the valve can not be adjusted.In order to verify whether the valve examined here has been influenced by the known risks of hydrocephalus therapy, as for example by natural substances (protein, blood or tissue particles) 1 in the cerebrospinal fluid, we have finally opened the progav valve.After opening the valve we were able to detect strong deposits, which might have impaired the adjustability of the valve.Based on our investigation results we can confirm that it was not possible to adjust the valve.The detectable strong deposits inside the valve presumably have caused the adjustment problems in the past.The presumed cause is one of the known, unchangeable risk of hctherapy by shunt implants.

• Brand Name: PROGAV SYST.PED.W/SA 20 A.PRECHAMBER
• Common Device Name: 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: 12916424
• Report Number: 3004721439-2021-00796
• Device Sequence Number: 5658086
• Product Code: JXG
• UDI-Device Identifier: 04041906132545
• UDI-Public: 4041906132545
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: FV441T-J
• Device Catalogue Number: FV441T-J
• Device Lot Number: 20016485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2017
• Initial Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown