MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 SYS W/SA10 A.CONTROL RESERV.; PREVIOUSLY REPORTED

Model Number FX432T

Device Problem Defective Device (2588)

Patient Problem No Code Available (3191)

Event Date 02/04/2020

Event Type  Injury  

Manufacturer Narrative

Possible lot number 20039562 (to be confirmed).Additional information / investigation results will be provided in a supplemental report, if applicable.

Event Description

It was reported that there was an issue with the shunt system.The patient was initially implanted with a progav valve with control reservoir.Sometime later, there was difficulty in re-programming noted.The clinical application specialist nor the surgeon could adjust the setting.There was a revision surgery to replace the defective valve.Additional information has been requested (including clarification on event date and awareness dates).

Event Description

Clarification was received: the first shunt, a non-aesculap device, was removed on (b)(6) 2018.A fx432t was then implanted.The original diagnoses had been pseudo tumor.The patient was revised to another progav2 valve on (b)(6) 2019; the reason for the revision was not specified.Some adjustments were made postoperatively.Sometime later, there was difficulty in re-programming noted.The clinical application specialist nor the surgeon could adjust the setting.The patient was examined and lay on her side; the low occipital valve was palpated directly under a wide keloidal scar.Although it was depressed, the adjustment did not occur.There was a revision surgery to replace the defective valve in (b)(6) 2020.Additional details on patient outcome were not provided.

Manufacturer Narrative

B: patient details, description updated.D: updated serial number and expiration date; product return date.H: production date.Investigation report: time schedule for the investigation - we received the progav 2.0 from aesculap usa inc.On (b)(6) 2020, reference number (b)(4).The progav 2.0 valve is a part from shuntsystem with the serial number (b)(6).The paedisa was not received for further investigation.We received the permission for investigation on (b)(6) 2020.With the release of this report the investigation is closed.Manufacturing and quality control data - the progav 2.0 shuntsystem was manufactured by a qualified employee in (b)(6)2018.Deviations during assembly did not occur.The system was sterilized by miethke and released for shipment after final inspection.For the purposes of this investigation, the progav 2.0 shuntsystem is comprised of a progav 2.0 adjustable valve and a shuntassistant fixed pressure valve.The progav 2.0 valve has a normal pressure range of 0 to 20 cmh2o.The paedisa has a fixed pressure of 10 cmh2o.The shuntsystem was inspected as article fx432t.All parameters (opening pressure, reflux, leak-proof/integrity of housing, adjustability and brake function) have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specifications.Before release, the progav 2.0 valve was pre-adjusted to a pressure setting of 5 cmh2o.Description of incoming product condition - the progav 2.0 valve was received submersed in an unidentified liquid in the provided in a plastic container.At the time of intake, the progav 2.0 valve was at a pressure setting of 12 cmh2o, patient information: age: 23 years; weight: 97 kg; height: 162 cm; date of implantation:(b)(6) 2019; date of removal: (b)(6) 2020.Visual inspection: in the first step of our investigations we carried out a visual inspection of the valve.Permeability test: to proof the penetrability of the shuntsystem we have carried out penetrability test.These test is carried out at a hydrostatic pressure in the direction of flow, calculated from the opening pressure of the adjustable valve plus 30 cmh2o.Adjustment test: our adjustment tests are carried out with the standard progav 2.0 check-mate and measurement tool.The progav 2.0 is adjusted from 0 to 20 cmh2o and down again in increments of 5 cmh2o.Braking force and brake function test: to measure the braking force, we tested the progav 2.0valve with a braking force apparatus.Here it is measured how much force must be exerted on the housing to release the rotor to adjust the valve by the integrated magnet of the braking force apparatus.Results : first we performed a visual inspection of the valve.No significant deformations or damage of the valve was detected during the visual inspection.Next we tested the permeability of the progav 2.0 at a hydrostatic high calculated from the opening pressure of the adjustable valve plus 30 cmh2o.The test results show that the progav 2.0 is permeable.Next we tested the braking force and brake functionality.The results show that the brake function is fully operational and the braking force is within the given tolerances.In order to verify whether the progav 2.0 is compromised by the known risks of hydrocephalus therapy, e.G.By a build-up of natural substances (protein, blood or tissue particles) in the cerebrospinal fluid, we have dismantled the valve.Inside the valve we have found build-up of substances (likely protein), which may have caused suspected malfunction in the past.Based on our investigation, we are unable to substantiate the claim of non-adjustability.The progav 2.0 valve is adjustable to all settings as specified.We can exclude a defect at the time of release.The shuntsystem met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.No further actions required.

• Brand Name: PROGAV 2.0 SYS W/SA10 A.CONTROL RESERV.
• Type of Device: PREVIOUSLY REPORTED
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam, 14469 ; GM 14469
• MDR Report Key: 9842244
• MDR Text Key: 183891913
• Report Number: 2916714-2020-00069
• 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: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2023
• Device Model Number: FX432T
• Device Catalogue Number: FX432T
• Device Lot Number: 20039562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/24/2020
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR
• Patient Weight: 97