MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 VALVE; PREVIOUSLY REPORTED

Model Number FX410T

Device Problems Defective Component (2292); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/05/2020

Event Type  Injury  

Manufacturer Narrative

If follow-up information/evaluation results are received, a supplemental report will be provided.

Event Description

It was reported that there was an issue with a prosa and progav 2.0 shuntsystem.The reporter indicated that there the valves were explanted.The valves had been initially implanted on an unspecified date, possibly at a different health care facility.A surgeon attempted to adjust the prosa valve from 12 to 14.Verified 12 setting and after adjustment valve went to 0.Attempted several times to move valve back to 14 and it was not moving from 0 setting.The surgeon made the decision to explant valves and implant a competitor's product.Additional information has been requested.Associated medwatches: 2916714-2020-00194.

Manufacturer Narrative

Updated information: b5 d section - serial and lot #, expiration date, explant date, manufacture date 03/30/2016 patient height 4'8 ft.Associated medwatches: 2916714-2020-00191, 2916714-2020-00194.Visual inspection: we have checked for possible damages, deformations of the housing or other abnormalities.The following observations were made during the visual inspection: deposits in the outlet spout.Permeability test: this test is carried out with the product in the horizontal position with a hydrostatic pressure difference of approx.30 cmh2o in the direction of flow.The test showed that the progav 2.0 is permeable.Adjustability test: thus indicating whether the valve is fully adjustable within the full range of specified pressure settings (in increments of 5 cmh2o).The progav 2.0 was found to be adjustable to all pressure settings.Braking force and brake function test a specific measurement device apparatus of braking force is used to investigate the braking force and the brake function of adjustable valves.This apparatus tests whether the braking function is present and how much force must be exerted on the housing to release the rotor to adjust the valve using the integrated magnet of the braking force apparatus.The braking force of the progav 2.0 was within the specified tolerance and the brake function operated as expected.After dismantling of the valve, slightly deposits were found in progav 2.0.Based on our investigation, we are not able to substantiate the claim of "programming issues".At the time of the investigation, it is not clear to us how the mentioned functional impairment occurred.Deposits caused by natural substances in the cerebrospinal fluid, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.Even small amounts of non-visible deposits might 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.From our point of view, no further regulatory actions are required.

Event Description

Updates provided: implantation: 2017; removal: (b)(6) 2020.

• Brand Name: PROGAV 2.0 VALVE
• Type of Device: PREVIOUSLY REPORTED
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 10164671
• MDR Text Key: 195990152
• Report Number: 2916714-2020-00191
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2021
• Device Model Number: FX410T
• Device Catalogue Number: FX410T
• Device Lot Number: 20029842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/15/2020
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 12 YR
• Patient Weight: 37