MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROSA VALVE HYDROCEPHALUS VALVES

Model Number FV701T

Device Problem Infusion or Flow Problem (2964)

Patient Problem Hydrocephalus (3272)

Event Date 10/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4). Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that a prosa shunt valve was removed due to a malfunction. A (b)(6) patient underwent a shunt system implantation on an unspecified date. Over a prolonged period of time, multiple valve adjustments were attempted; finally, when the desired opening pressure was achieved, overdrainage occurred. This issue led to removal of the device on (b)(6) 2018. It was noted that the patient was being treated for pseudotumor cerebri hydrocephalus. Further details have been requested but not yet received.

Manufacturer Narrative

Scratches to, and a deformation of, the outer housing of the valve was observed through the visual inspection. The prosa valve housing was subsequently measured and confirmed the presence of a deformation. The housing deformation measured at -0. 730mm, outside the tolerance of 0±0. 02mm. A permeability test has indicated that the valve has blockage. The valve was tested and is adjustable to all specified pressures. The break functionality test has shown that the brake function is fully operational and within tolerances. A miethke computer controlled testing apparatus was used to test the opening pressure which simulates a cerebrospinal fluid flow. Because the valve is not permeable, the computer controlled test is not possible. The valve was dismantled and inside the valve a build-up substance (likely protein) was found. Based on our investigation, we are unable to substantiate the claim of non-adjustability, the valve was found to be adjustable to all specified settings. We were unable to investigate the claim of over-drainage due to the non-permeability of the valve. However, it is possible that the deposits observed inside the vale could have caused the presumed over-drainage in the past. As describe in our literature, the problem encountered is one of the known, inevitable risks of hc therapy by shunt implants. The cause of the deformation of the prosa valve could not be determined through out investigation. It should be noted that significant outside pressure, for example by too much force from the prosa adjustment tool or by a fall or impact to the head of the patient, can compromise the integrity of the valve. We can exclude a defect at the time of release. The valve met all specifications of the final inspection when released from (b)(6) (b)(4).

• Brand Name: PROSA VALVE
• Type of Device: HYDROCEPHALUS VALVES
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 8126734
• MDR Text Key: 129147646
• Report Number: 3004721439-2018-00288
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K161853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: FV701T
• Device Catalogue Number: FV701T
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Distributor Facility Aware Date: 12/05/2018
• Event Location: No Information
• Date Manufacturer Received: 12/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/03/2018 Patient Sequence Number: 1