MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV VALVE; HYDROCEPHALUS MANAGEMENT

Model Number FV410T

Device Problems Obstruction of Flow (2423); Free or Unrestricted Flow (2945)

Patient Problems Failure of Implant (1924); Hydrocephalus (3272)

Event Date 02/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Patient information: height (b)(6).When additional information is received a follow up report will be submitted.

Event Description

It was reported by the healthcare professional "4 year 11 month po overdrain of the valve." additional patient information has been requested.When additional information is received a follow up report will be submitted.All med watch submissions related to this patient are: 3004721439-2019-00056 (this report), 3004721439-2019-00057.

Manufacturer Narrative

G1/g2: contact information updated due to expiration of exemption e2014018.Manufacturing site evaluation: manufacturing records show that this progav valve was manufactured by a qualified employee in october 2007.No deviations were identified during assembly.The valve was inspected as article fv410t.The valve has a normal pressure range of 0 to 20 cmws.All required parameters were approved and product specifications met during the manufacturing process.Following final inspection, the valve was sterilized by miethke and released for shipment.Investigation: the valve was received for analysis submersed in an unidentified liquid within a plastic container.Initial visual examination found a deformation of the outer housing of the valve.When measured, the housing deformation was confirmed to be -0.0735 mm, outside the tolerance of 0 +/- 0.02 mm.Testing: permeability testing confirmed the valve is permeable.During adjustment testing, the valve was adjustable to all specified pressures.Brake functionality testing found the brake function does not operate as expected.The results indicate that the rotor no longer performs as required, allowing the valve to self-adjust.To evaluate reports of over drainage, the opening pressure of a valve is typically tested using a miethke computer controlled testing apparatus which simulates cerebral spinal fluid flow.However, in this case that was not possible due to the compromised brake functionality.Finally, the valve was dismantled.A significant build-up of substances (likely protein) was identified at that time.No further anomalies were identified and all other specifications were met.Conclusion: based on our investigation, we were unable to substantiate the report of over-drainage as it was not possible to perform the necessary test, as described above.Although no specific conclusions can be drawn, it is likely that difficulty encountered relates to the deposits observed within the valve during the analysis.We can exclude manufacturing defects at the time of product release as the valve was confirmed to have met all specifications of the final inspection.As described in our literature, this is a known, inherent risk of hc-therapy involving shunt implants and no manufacturing relationship is established.The cause of the housing deformation could not be determined with certainty.Significant outside pressure, for example excessive force from a progav adjustment tool or by a fall or impact to the patient's head, can compromise the integrity of the valve.No manufacturing relationship is established.Reports of this type will continue to be monitored.At this time, no trend for reports of this type has been identified.

• Brand Name: PROGAV VALVE
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 8384019
• MDR Text Key: 137671937
• Report Number: 3004721439-2019-00056
• 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: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2012
• Device Model Number: FV410T
• Device Catalogue Number: FV410T
• Device Lot Number: 4501220299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Distributor Facility Aware Date: 02/15/2019
• Device Age: 12 YR
• Date Manufacturer Received: 02/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR
• Patient Weight: 30