MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS W/SA20 A.CONTROL RESERV.; HYDROCHEPHALUS MANAGEMENT

Model Number	FV434T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	02/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product received to date.Should relevant additional information/investigation results become available, an additional medwatch report will be submitted.
Event or Problem Description
It was reported that a progav 2.0 shunt system (part # fx434t) was implanted during a procedure performed on an unknown date.According to the complainant, the system was believed to be operated in not adjustable.The patient underwent a revision procedure.The complaint device has not yet returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.
Additional Manufacturer Narrative
Corrected data - g4 (pma/510k #) visual inspection: in the first step of our investigation, we performed a visual inspection of the product.We have checked for possible damage, deformation of the housing, deposits or other abnormalities.The following observations were made during the visual inspection: - deformation of the housing, progav - bloody deposits, shunt assistant.- deposits on the connecting cathter measurement of surface of the housing: to verify whether the deformation had an effect on the plane-parallelism of the housing surface, this was measured using a dial gauge.Deformation detected: measured value: -0,038 mm [tolerance (0 ± 0.02mm)] too much pressure on the valve, for example through the adjustment tool or resulting from a fall or hit to the head of the patient, can compromise the integrity of the valve.Permeability test: the permeability test was performed at a hydrostatic pressure difference of the pressure setting of the progav shunt system upon receipt plus 30 cmh2o in the horizontal direction of flow.The test showed that the progav shunt system is permeable.Computer control test: to check the flow rate of the valves, the valves were tested on a miethke computer controlled testing apparatus and passed the standard test.The flow of the test liquid was reduced step by step from 60 ml/h to 5 ml/h (in accordance with iso 7197).Distilled water was used as the test-liquid.The resulting pressure was measured.A test bench measurement on the progav is not meaningful due to the failure of the brake function, since the valve cannot keep the set opening pressure with a defective brake.The shunt assistant was tested according to standard procedure in the vertical position.The results indicated that at a reference flow of 20 ml/h in the vertical position, the shunt assistant had a pressure of 18,25 cmh2o.This is within the specified tolerance of 20 cmh2o -2 / +4 cmh2o.Adjustability test: in this step, it was investigated whether the adjustable progav can be successfully set to each specified pressure setting.It was checked whether the valve is fully adjustable within the full range of specified pressure settings (in increments of 5 cmh2o).The progav could be adjusted in all pressure ranges.However, this was possible without any force, since the brake function failed, this has no significance.The shuntassistant is a fixed pressure valve, therefore the adjustability test is inapplicable.Braking force and brake function test: the braking force and brake function test investigates whether the brake function of the adjustable valves is present and how much force must be exerted on the housing to release the rotor to adjust the valves using the integrated magnet of a specific measurement apparatus of braking force.The brake function of the progav did not operate as expected.Due to the non-functionality of the brake function the braking force of the progav is unable to be measured.Internal inspection of product: in order to verify whether the investigated shunt system was compromised by the known risks of hydrocephalus therapy, e.G.By a build-up of natural substances (protein, blood, or tissue particles) in the cerebrospinal fluid, the valves are finally opened with a special tool.After dismantling of the valves, deposits were found inside.For more detailed visibility, the proteins/deposits in the valves were colored by using a colouring solution.[colouring solution consisting of coomassi brilliant blue r mixed with 0.6% ethanol and distilled water].Results: based on our inspection results, we can determine, at the time of our inspection, damage at the housing, a failure of the brake function as well as deposits at the progav.The cause for the failure of the brake function on the progav is the damage to the housing and the deposits.In the case of the shuntassistant, we were able to detect deposits.The deposits had no affect on the technical properties at the time of the investigation.Existing deposits in the csf can temporarily impair the function of the valve and is described as concomitant symptoms in hydrocephalus therapy.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.Further actions: from our point of view, no further regulatory actions are required.Return of product: we will return the investigated product to the sender for our own relief.
Event or Problem Description
It was reported that a progav shunt system (#fv434t) was implanted during a procedure on (b)(6) 2015.According to the complainant, the progav showed an under-drainge and adjustment difficulties.The patient underwent a revision procedure on (b)(6) 2023.The complaint device has returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: (b)(6) weight: 53.8 kilograms (kg) height: 150 centimeters (cm) gender: female.

• Brand Name: PROGAV 2.0 SYS W/SA20 A.CONTROL RESERV.
• Common Device Name: HYDROCHEPHALUS 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: 16518446
• Report Number: 3004721439-2023-00050
• Device Sequence Number: 12327076
• Product Code: JXG
• UDI-Device Identifier: 04041906132460
• UDI-Public: 4041906132460
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2023

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: 01/12/2019
• Device Model Number: FV434T
• Device Catalogue Number: FV434T
• Device Lot Number: G46105C51192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2014
• 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: Female
• Patient Weight: 53 KG