MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV WITH SHUNTASSISTANT 20; HYDROCEPHALUS MANAGEMENT

Model Number	FV413T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	08/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: (description incoming product condition); the valve was returned submersed in a unidentified liquid in the provided return kit.Result: first we performed a visual inspection of the progav.There were no significant deformations or damage of the valve were detected during the visual inspection.Next we tested the permeability, adjustability, brake functionality and brake force.The valve is permeable, albeit with difficulty.The brake is not functional, therefore it was not possible to adjust the valve.The cause of the defect of the braker could not be determined through our investigation.Significant outside pressure, for example by to much force on the adjustment tool or by a fall or impact to the head of the patient, can compromise the integrity of the valve.Finally, we dismantled the valve.Inside the valve we have found a build-up of substances (likely protein).Based on our investigation, we confirm that the valve was not adjustable at the time of the investigation.The cause of the malfunction remains unclear.As described in scientific literature, the deposits 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.
Event or Problem Description
According to the complainant a progav was blocked and not adjustable postoperatively.The valve was implanted on (b)(6) 2014.It was removed on (b)(6) 2021 due to the malfunction and returned to the manufacturer.Further details were not provided.

• Brand Name: PROGAV WITH SHUNTASSISTANT 20
• 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: 12940131
• Report Number: 3004721439-2021-00806
• Device Sequence Number: 4790191
• Product Code: JXG
• UDI-Device Identifier: 04041906132101
• UDI-Public: 4041906132101
• 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: 2014
• 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): 12/06/2021

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: 06/30/2018
• Device Model Number: FV413T
• Device Catalogue Number: FV413T
• Device Lot Number: 20021860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2017
• Initial Report FDA Received Date: 12/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2013
• 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: 3.5 YR
• Patient Sex: Unknown