MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SA20 A.CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX478T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	08/30/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the complainant a progav was "had a defect" postoperatively.The valve was implanted in (b)(6) 2017.It was removed on (b)(6) 2017 due to the malfunction and returned to the manufacturer.Further details were not provided.Height: 170 cm.
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: (description incoming product condition).The shunt system was dry via the provided returnkit (not submerged, as suggested).Result: first we performed a visual inspection of the valve.No significant deformations or damage of the valve were detected during the visual inspection.Next we tested the permeability, adjustability, opening pressure, and brake functionality and brake force.The valve was permeable.First the valve could only be adjusted in the pressure ranges of 10-20 cmh2o.In the ranges from 0-9 cmh2o, it was not adjustable.After measuring braking force/function, the valve could be adjusted to all pressure stage ranges without any problems.We assume that while testing the brake, and stuck deposits were loosened.The brake is fully functional and the braking force is within given tolerances.The first measurement of the opening pressure in the horizontal body position has shown that the valve is outside the permissable tolerance.The valve tends to underdrain.The measured values of the second measurement were still outside tolerance, but an improvement in the values could be observed.Presumably further testing would lead to continued improvement of the values, since the distilled water would flush any deposits inside the valve out of it.Finally, we dismantled the valve.Inside the valve we have found a small build-up of substances (likely protein).Based on our investigation, we confirm the presence of deposits in the valve at the time of our investigation, which could have caused the malfunction.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hc-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 miehtke gmbh & co.Kg.No further actions required.

• Brand Name: PROGAV 2.0 WITH SA20 A.CONTROL RESERVOIR
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• 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: 12984478
• Report Number: 3004721439-2021-00814
• Device Sequence Number: 12176444
• Product Code: JXG
• UDI-Device Identifier: 04041906137113
• UDI-Public: 4041906137113
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K141687
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/13/2021

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: 06/30/2021
• Device Model Number: FX478T
• Device Catalogue Number: FX478T
• Device Lot Number: 20031539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2017
• Initial Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2016
• 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 Age: 50 YR
• Patient Sex: Unknown
• Patient Weight: 110 KG