MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROSA SYS W/ADJ.DP.UNIT A.CONTROL RES.; HYDROCEPHALUS MANAGEMENT

Model Number	FV770T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	10/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual inspection: visual inspection showed the following: prosa® with deformations and scratches, progav® with deformations, control reservoir with external deposits.Permeability test: the investigation has shown that the prosa® is not permeable, while the progav® and the control reservoir are permeable.Adjustment test: both valves could be adjusted in all pressure ranges, however, this could be done without applying any force.The brake function is no longer given and the pressure stages cannot be held.Braking force and brake function test: the function of the brake could no longer be checked on either valve.It is therefore not possible to measure the braking force.Computer controlled test: to investigate the claim of over-drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.A test bench measurement of the prosa® and progav® is not meaningful due to the detected failure of the brake function, as the valves cannot maintain the set opening pressure in the event of a defective brake.Internal inspection : after dismantling of the valve, deposits were found in prosa® und progav 2.0.Results: the test results show a blockage on the prosa® as well as a deformed housing surface and a failure of the brake function on both valves.The cause of the blockage may be the deposits found, the cause of the failure of the brake function may be the deformations of the housing surfaces found.Deposits caused by substances naturally present in the body, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.Even small amounts of protein can compromise the integrity of the valve.High pressure exerted, for example by the adjustment instrument or a fall or blow to the patient's head, can compromise the integrity of the valve.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.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 a prosa shunt system with progav (part # fv770t) was implanted during a procedure performed on (b)(6) 2016.According to the complainant, the shunt system was believed to be operated in overdrainage and not adjustable.The patient underwent a revision procedure performed on (b)(6) 2022.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 28 years.Height: 180 centimeters (cm).Weight: 90 kilograms (kg).Gender: male.

• Brand Name: PROSA SYS W/ADJ.DP.UNIT A.CONTROL RES.
• 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: 15849754
• Report Number: 3004721439-2022-00352
• Device Sequence Number: 6429126
• Product Code: JXG
• UDI-Device Identifier: 04041906135553
• UDI-Public: 4041906135553
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K120559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/22/2022

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: 07/12/2020
• Device Model Number: FV770T
• Device Catalogue Number: FV770T
• Device Lot Number: 20027232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2015
• 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: 28 YR
• Patient Sex: Male
• Patient Weight: 90 KG