MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 W/SA2.0 25 & PED.CONTROL RES.; HYDROCEPHALUS MANAGEMENT

Model Number	FX674T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	07/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The same event: medwatch#3004721439-2021-00218.Investigation: visual inspection: no significant deformations or damage of the valve were detected during the visual inspection.Permeability test: a permeability test has shown that the valve and the prechamber are permeable.Bloody liquid drained out during the test.Adjustment test: the progav 2.0 was tested and is adjustable to all specified pressures.Braking force and brake function test: the brake functionality test has shown that the brake function is fully operational and the braking force is within the given tolerances.Result: first, we performed a visual inspection of the progav 2.0 and the prechamber.No significant deformations or damage of the valve were detected during the visual inspection.Next, we tested the permeability, adjustability, as well as the brake functionality and brake force.The valve operates as expected and met all specifications.Finally, we have dismantled the valve.Inside the valve we have found a build-up of substances (likely protein).Based on our investigation, we are unable to substantiate the claim of occlusion.At the time of our investigation, the valve was shown to be permeable.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 miethke gmbh & co.Kg.No further regulatory actions are required from our point of view.
Event or Problem Description
It was reported that a progav 2.0 (#fx674t) was implanted during a procedure performed on (b)(6) 2020.According to the complainant, the valve was believed to have a blockage.The patient underwent a revision procedure.The complainant device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: (b)(6) years, height: 184 cm, weight: (b)(6) kg, gender: unknown.The same event: medwatch#3004721439-2021-00218.

• Brand Name: PROGAV 2.0 W/SA2.0 25 & PED.CONTROL RES.
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12289245
• Report Number: 3004721439-2021-00217
• Device Sequence Number: 3839918
• Product Code: JXG
• UDI-Device Identifier: 04041906502287
• UDI-Public: 4041906502287
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2021

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: 09/21/2025
• Device Model Number: FX674T
• Device Catalogue Number: FX674T
• Device Lot Number: 20049756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2021
• Initial Report FDA Received Date: 08/06/2021
• 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: 53 YR
• Patient Weight: 83