MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 VALVE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number FX410T

Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964)

Patient Problems Irritability (2421); Weight Changes (2607)

Event Date 02/10/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturer evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

It was reported to aesculap inc.That a progav 2.0 valve (part # fx410t) was implanted during a procedure performed on (b)(6) 2020.According to the complainant, the valve, which was found to be stuck on 8 during the last attempt to reprogram on (b)(6), 2020, was allowing no egress of cerebrospinal fluid (csf).Additionally, the patient experienced protracted irritability and anorexia.The patient underwent a revision procedure on (b)(6) 2021 and had another manufacturer's device implanted at that time.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision surgery.Patient information: age: (b)(6), height: 78 cm, weight: (b)(6), gender: female.Implantation: (b)(6) 2020.Explantation: (b)(6) 2021.

Event Description

No changes.

Manufacturer Narrative

Investigation: visual inspection: the following observations were made during the visual inspection: deposits in the inlet spout.Permeability test: the test showed that the progav 2.0 is permeable.Computer control test: the computer controlled test has shown the opening pressure of the progav 2.0, at a reference flow rate of 20 ml/h in a horizontal position, to be 1.88 cmh2o.This is not within the specified tolerance of 9 cmh2o ± 3 cmh2o.Additional testing did not significantly change the results.According to our results, we can confirm the presence of an accelerated outflow.Adjustability test: the progav 2.0 was not adjustable within the specified range.Braking force and brake function test: the braking force test indicates that the brake function of the progav 2.0 is present.Due to the non-adjustability of the valve is the investigation of the braking force not possible.Internal inspection of product: in order to verify whether the investigated valve was 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.After dismantling of the valve, some deposits were found in progav 2.0.Results: based on our investigation, we are able to substantiate the claim of "non- adjustability".We are unable to confirm a slower outflow.We are assuming that the deposits detected within the valve have caused the functional impairment.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.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.

• Brand Name: PROGAV 2.0 VALVE
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 11506914
• MDR Text Key: 254546702
• Report Number: 2916714-2021-00032
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 04041906136529
• UDI-Public: 4041906136529
• 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: 03/17/2021,03/26/2021

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: 09/06/2023
• Device Model Number: FX410T
• Device Catalogue Number: FX410T
• Device Lot Number: 20039159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/17/2021
• Distributor Facility Aware Date: 02/15/2021
• Device Age: 29 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/15/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/17/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 19 MO
• Patient Weight: 10