MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYS W/SA 15 A.CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FV448T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	11/04/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: the valve was received submersed in an unidentified liquid in the provided returnkit.Visual inspection: no significant deformations or damage of the valve were detected during the visual inspection.The valve housing was subsequently measured and indicated the presence of a deformation.The measured valve was slightly out of tolerance.Result: first, we performed a visual inspection of the progav.No significant deformations or damage of the valve were detected during the visual inspection.But a deformation was detected through a measurement of the plan parallelity.Next, we tested the permeability, adjustability,as well as the brake functionality and brake force.The valve was reduced permeable but could not be adjusted to all settings.The brake function operates as expected.However, the breaking force required was not within the given specifications.Finally, we have dismantled the valve.Inside the valve we have found a build-up of substances (likely protein).Based on our investigation, the valve was shown to be reduced permeable.We are assuming that the deposits detected within the valve have caused the functional impairment.Deposits caused by natural substances in the cerebrospinal fluid, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miethke (b)(4).No further actions required.
Event or Problem Description
According to the complainant a progav was suspected of postoperative blockage.The patient was originally implanted on (b)(6) 2013.The revision date was (b)(6) 2016.The valve was explanted and returned to the manufacturer for evaluation.Further details were not provided.

• Brand Name: PROGAV SYS W/SA 15 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: 12506493
• Report Number: 3004721439-2021-00657
• Device Sequence Number: 14744731
• Product Code: JXG
• UDI-Device Identifier: 04041906137298
• UDI-Public: 4041906137298
• 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 Implanted Year: 2013
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2021

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 Model Number: FV448T
• Device Catalogue Number: FV448T
• Device Lot Number: 20016304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2016
• Initial Report FDA Received Date: 09/21/2021
• 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: 3.75 YR