MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYS W/SA 20 A.CONTROL RESERVOIR; HYDROCEPHALUS VALVES

Model Number	FV434T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	08/23/2017
Type of Reportable Event	Serious Injury
Additional 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 were observed through the visual inspection.The measurement of the plane parallelism could confirm that with a value of -0,069mm the housing membrane is clearly outside tolerance (0 ± 0.02 mm).Permeability test: a permeability test has indicated that the valve has a blockage.Adjustment test: the progav® was tested and is not adjustable throughout the normal range.Braking force and brake function test: the brake functionality test has confirmed that the valve properties were affected by the apparent deformation.Result: first, we performed a visual inspection of the progav®.A significant deformation of the outer housing of the progav® valve was 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 progav® adjustment tool or by a fall or impact to the head of the patient, can compromise the integrity of the valve.Next, we tested the permeability, adjustability, as well as the brake functionality and brake force.The valve is not permeable and not adjustable to any pressure levels.It was not possible to test the brake function and measure the braking force.A deformation can cause the lowering of the housing diaphragm, which due to the preload set, generates the braking force, which is supposed to hold the rotor in its position.This is no longer the case due to the deformation.The brake is defective.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 that the valve was non-adjustable at the time of our investigation.The cause of the deformation of the progav® valve and the resultant defect of the rotor could not be determined through our investigation.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.No further regulatory actions are required from our point of view.
Event or Problem Description
It was reported that a progav sys w/sa 20 a.Control reservoir (# fv434t) was implanted during the procedure on unknown date.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.

• Brand Name: PROGAV SYS W/SA 20 A.CONTROL RESERVOIR
• 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: 12968976
• Report Number: 3004721439-2021-00820
• Device Sequence Number: 4572934
• Product Code: JXG
• UDI-Device Identifier: 04041906132460
• UDI-Public: 4041906132460
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K103003
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2014
• Device Model Number: FV434T
• Device Catalogue Number: FV434T
• Device Lot Number: 20009495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2017
• Initial Report FDA Received Date: 12/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2009
• 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: 8 YR
• Patient Sex: Unknown