MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS PED.W/SA20 A.BURRHOLE RES; HYDROCEPHALUS MANAGEMENT

Model Number	FX448T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	03/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product for investigation has not yet reached us.When additional informations are provided a follow up will be submitted.
Event or Problem Description
On (b)(6) 2020 it was reported that there was a problem with a progav 2.0 shuntsystem.The shuntsystem is blocked.Patient information: date of implantation: (b)(6) 2018; date of removal: (b)(6) 2020; age y: (b)(6); height cm: (b)(6); weight kg: (b)(6); gender: na.
Additional Manufacturer Narrative
The investigation was done on 11/11/2020.Visual inspection: the following observations were made during the visual inspection: no abnormalities were observed.Permeability test: the test showed that the progav 2.0 is permeable.Adjustability test: the progav 2.0 was found to be not fully adjustable to specifications.Braking force and brake function test: the braking force test indicates that the brake function of the progav 2.0 is present.Due to the non-adjustability of the valve, as detailed in section 7.3, an investigation of the braking force was not possible.Internal inspection of product: in order to verify whether the investigated valve 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, we have dismantled the valve.After dismantling of the valve, some deposits were found in progav 2.0.Results: we would like to note in advance that the returned product was removed in (b)(6) 2020.The testing of valves, sent in after so long period of time after explantation, is of limited value.Product performance can be affected by dry residues of cerebrospinal fluid, blood or storage conditions.Nevertheless, we have tested the valve to the best of our knowledge and belief.Based on our investigation, we are able to substantiate the claim of "blockage".The valve is not adjustable.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 gmbh & co.Kg.From our point of view, no further regulatory actions are required.
Event or Problem Description
The product was received on 11/06/2020 for investigation.Only the progav 2.0 valve was send in.The investigation could be performed.Date of implantation: (b)(6) 2018.Date of removal: (b)(6) 2020.

• Brand Name: PROGAV 2.0 SYS PED.W/SA20 A.BURRHOLE RES
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 10743694
• Report Number: 3004721439-2020-00215
• Device Sequence Number: 3312548
• Product Code: JXG
• UDI-Device Identifier: 04041906137748
• UDI-Public: 04041906137748
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2020

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: 07/25/2022
• Device Model Number: FX448T
• Device Catalogue Number: FX448T
• Device Lot Number: 20034731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 12/09/2020
• 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: 4 YR
• Patient Weight: 20