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

Model Number	FV434T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	08/02/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the complainant a progav was not adjustable postoperatively.The valve was implanted on (b)(6) 2015.The valve was explanted on (b)(6) 2017 and returned to the manufacturer.Further details were not provided.Height: 57 cm.
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: (description incoming product condition): the valve was received submersed in an unindented liquid via the provided returnkit.Result: first we performed a visual inspection of the valve.No significant deformations or damage of the valve were detected.The measurement of the plane parallelism could confirm this.Next we tested the permeability, adjustability, as well as the brake functionality and braking force.The valve was not permeable throughout the normal range.Presumably deposits affected the function of the valve.The brake functionality test has shown that the brake function is operational.The braking force cannot be measured due to the non-adjustability of the valve.Next, we have dismantled the valve.Inside we have found a buildup of substances.Based on our investigation, we can confirm that the valve was non-adjustable 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.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miehtke gmbh & co.Kg.No further actions required.

• Brand Name: PROGAV SYS W/SA 20 A.CONTROL RESERVOIR
• 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: 12989557
• Report Number: 3004721439-2021-00823
• Device Sequence Number: 5275051
• Product Code: JXG
• UDI-Device Identifier: 04041906132460
• UDI-Public: 4041906132460
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K031303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/13/2021

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: 12/31/2019
• Device Model Number: FV434T
• Device Catalogue Number: FV434T
• Device Lot Number: 20026834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2017
• Initial Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2015
• 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 Sex: Unknown
• Patient Weight: 4 KG