MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV SYS W/SA 25 A.CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number FV435T

Device Problem Reset Problem (3019)

Patient Problem Hydrocephalus (3272)

Event Date 03/08/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Patient data - height: 170 cm.Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that a progav valve had an adjustment issue.A patient underwent a retro-auricular shunt system implantation on (b)(6) 2019.Sometime later, an adjustment defect was noted.On (b)(6) 2019, the shunt was replaced due to this malfunction.Further details were not available.

Manufacturer Narrative

Visual inspection: a deformation of, as well as bloody deposits on, the outer housing of the progav valve was observed through the visual inspection.The progav valve housing was subsequently measured and confirmed the presence of a deformation.The housing deformation measured at -0.0715mm, outside the tolerance of 0+- 0.02mm.Permeability test: a permeability test has shown that the progav valve is permeable.Adjustment test: the progav valve was tested and is freely adjustable.However, the test also showed that the brake function is not present, allowing the valve to self-adjust.Braking force and brake function test: the brake functionality test has shown that the brake function did not operate as expected.The results indicate that the rotor no longer performs as required.Results: it should be noted the shunt system was received dry (not submerged in liquid as recommended).The investigation of dry items is not significant due to the affect dry deposits of liquid and blood can have on product performance.In spite of this, we have investigated the system to the best of our abilities.First, we performed a visual inspection of the progav valve.A deformation of the outer housing of the progav valve was observed through the visual inspection the deformation was confirmed through a measurement of the paralitity of the valve housing.Next, we tested the permeability of the valve, as well as the brake functionality and brake force.The progav valve was permeable.However, the brake function was not present allowing the valve to self-adjust and indicating that the rotor has been compromised.Finally, we have dismantled the valve.Inside the valve, we have found build-up of substances (likely protein).Based on our investigation, we confirm that the brake function of the valve no longer operates as expected; this is likely due to the observed deformation of the valve housing.Additionally, the deposits observed inside the valve could have contributed to the compromise of the system.As described in our literature, the problem encountered is one of the known, inevitably risks of hc-therapy by shunt implants.The cause of the deformation of the progav valve and the resultant defect of the rotor could not be determined though out investigation.Significant outside pressure, for example by too much force from the pogav adjustment tool or by a fall or impact to the head of the patent, 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 christoph miethke gmbh & co.Kg.

• Brand Name: PROGAV SYS W/SA 25 A.CONTROL RESERVOIR
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 8487823
• MDR Text Key: 141073427
• Report Number: 3004721439-2019-00083
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K103003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/08/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 10/08/2023
• Device Model Number: FV435T
• Device Catalogue Number: FV435T
• Device Lot Number: 20039502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Distributor Facility Aware Date: 03/21/2019
• Initial Date Manufacturer Received: 03/18/2019
• Initial Date FDA Received: 04/05/2019
• Supplement Dates Manufacturer Received: 04/03/2019
• Supplement Dates FDA Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 100