MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROSA SYS M.VERST.DD.EINHEIT U.CONT.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	10/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a prosa shuntsystem (part # fv770t) was implanted during a procedure performed on (b)(6) 2018.According to the complainant, the shunt system was believed to be operated in under-drainage and was not adjustable.The patient underwent a revision procedure on (b)(6) 2021.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: (b)(6), height: 168 centimeters (cm), weight: (b)(6) kilograms (kg), gender: male.
Additional Manufacturer Narrative
Manufacturing and quality control data: the prosa® shunt system was manufactured by a qualified employee in september 2019.Deviations during assembly did not occur.The system was sterilized by miethke and released for shipment after final inspection.For the purposes of this investigation, the prosa® shunt system is comprised of a prosa® adjustable pressure valve with a normal pressure range of 0 to 40 cmh2o and a progav® adjustable pressure valve with a normal pressure range of 0 to 20 cmh2o.The shunt system was inspected as article fv770t.All parameters have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specifications.Visual inspection: no significant deformations or damage of the valves were detected during the visual inspection.Permeability test: a permeability test has shown that both valves are permeable.Computer controlled test: to investigate the claim of under-drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valves are tested in both the horizontal as well as the vertical positions.The results show that the progav® is operating within the accepted tolerance in the horizontal position.The prosa® is operating not within the specified tolerances in the vertical position.Adjustment test: the prosa® was tested is not adjustable throughout the normal range and the progav® is adjustable to all specified pressures.Braking/ klick force and brake function test: the brake functionality test of the progav® has shown that the brake function is fully operational and the braking force is within the given tolerances.The brake of the prosa® function is operational, however the braking force cannot be measured due to the non-adjustability of the valve.Internal inspection : after dismantling of the valves, tiny amounts deposits were found in both valves.Results: based on our investigation, we confirm that the valve shows an increased flow of liquid at the time of our investigation.This is likely due to the deposits observed inside the valves.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.No further regulatory actions are required from our point of view.

• Brand Name: PROSA SYS M.VERST.DD.EINHEIT U.CONT.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: 12821095
• Report Number: 3004721439-2021-00303
• Device Sequence Number: 5760837
• 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: 2018
• Device Explanted Year: 2021
• 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
• Report Date (Section B): 11/16/2021

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: 09/18/2022
• Device Model Number: FV770T
• Device Catalogue Number: FV770T
• Device Lot Number: 20035154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2017
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 96 KG