MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYS W/SA 25 A.CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FV435T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	10/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual inspection: a deformation of the outer housing of the progav valve and the bloody delivery liquid was observed through the visual inspection.The progav valve housing was subsequently measured and confirmed the presence of a deformation.The housing deformation measured at -0.06 mm, outside the tolerance of 0 ± 0.02 mm.Permeability test: a permeability test has shown that both valves are permeable.Bloody liquid was flushed out during this test.Adjustment test: the progav valve has been tested and can be adjusted to all specified pressures without any effort of power.The braking function is no longer present.Braking force and brake function test: the brake functionality test has shown that the brake function did not operate as expected.The results indicate that the rotor no longer performs as required.The brake force cannot be measured because of the dysfunction of the brake.Results: first, we performed a visual inspection of the progav shunt system.A deformation of the outer housing of the progav valve was observed through the visual inspection.The deformation was confirmed through a measurement of the parallelism of the valve housing.Next, we tested the permeability.Both valves were shown to be permeable.Bloody test liquid was flushed out during this test.Additionally, we tested the adjustability as well as the brake functionality and brake force of the progav valve.The valve was adjustable to all settings, however the brake function did not operate as expected.Finally, we have dismantled the valves.In the progav were minimal visible deposits and in the shunt assistant were no visible deposits observed.Based on our investigation, we are unable to substantiate the claim of occlusion.At the time of our investigation, the valves were shown to be permeable.But we confirm the presence of "self-adjustment".The cause of the deformation of the progav valve and the resultant defect of the rotor could not be determined through our investigation.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.Despite the lack of significant deposits, it is possible that even non-visible or small amounts of build-up could have led to a temporary compromise of the valve and to the observed malfunction in the past.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 shunt system 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 there was a problem with a progav valve.The progav adjusted itself and the surgeon suspected a blockage.Patient information age: (b)(6).Weight: (b)(6).Height: (b)(6).Gender: unknown.Date of implantation: unknown.Date of removal: (b)(6) 2020.

• Brand Name: PROGAV SYS W/SA 25 A.CONTROL RESERVOIR
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 10785384
• Report Number: 3004721439-2020-00227
• Device Sequence Number: 3025090
• Product Code: JXG
• UDI-Device Identifier: 04041906132477
• UDI-Public: 4041906132477
• 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: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2020

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: 08/13/2019
• Device Model Number: FV435T
• Device Catalogue Number: FV435T
• Device Lot Number: 20024046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Weight: 80