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	09/06/2017
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) 2011.The valve was explanted on (b)(6) 2017 and returned to the manufacturer.Further details were not provided.
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: (description incoming product condition).The valve was received submersed in an unidentified liquid via the provided returnkit.Result: first we performed a visual inspection of the valve.Although no significant deformations or damage of the valve were detected, the measurement of the plane parallelism has revealed that the valve is outside tolerance of 0+/-0.02mm.Significant outside pressure, for example by too much force from the adjustment tool or by a fall or impact to the head of the patient, can compromise the integrity of the valve.The measurement of the brake release force has also revealed that more force must be exerted to release the brake.The measurement values were outside the permissible tolerance.We assume that the brake function was impaired by the deformation of the housing diaphragm.The valve is permeable and adjustable to all specified pressures.Next, we have dismantled the valve.Inside we have found a buildup of substances (likely protein).As described in scientific literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.Based on our investigation, we are unable to substantiate the claim of non-adjustability, even though more force must be applied to adjust the valve.At the time of our investigation, the valve was able to be adjusted to all specified settings.However, it is possible that a combination of the deposits observed inside the valve and the deformation on the housing could have caused the malfunction in the past.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 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: 12990372
• Report Number: 3004721439-2021-00822
• Device Sequence Number: 20148957
• Product Code: JXG
• UDI-Device Identifier: 04041906132101
• UDI-Public: 4041906132101
• 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: 2011
• 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: 05/26/2016
• Device Model Number: FV413T
• Device Catalogue Number: FV413T
• Device Lot Number: 20013955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• 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: 05/31/2011
• 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: 12.2 YR
• Patient Sex: Unknown
• Patient Weight: 52 KG