MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 VALVE; HYDROCEPHALUS MANAGEMENT

Model Number FX410T

Device Problem Infusion or Flow Problem (2964)

Patient Problem Hydrocephalus (3272)

Event Date 08/22/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturing and quality control data the progav®2.0 was manufactured by a qualified employee in august 2015.Deviations during assembly did not occur.The valve was sterilized by miethke and released for shipment after final inspection.The progav®2.0 has a normal pressure range of 0 to 20 cmh2o.The valve was inspected as article fx410t.All parameters have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specifications.Incoming product condition: the valve was received submersed in an unidentified liquid in the provided returnkit.The complaint device was strongly contaminated with bloody liquid and tissue residues.Results testing of contaminated valves are of limited value.The device characteristics may be influenced by the presence of cerebrospinal fluid or blood residues.As previously indicated, the complaint sample was received submerged in a bloody liquid and was contaminated with tissue residue.Subsequently, the device was classified as high risk to staff and for hygiene reasons, a device evaluation was not able to be performed.Therefore, a definitive conclusion regarding the complaint incident was unable to be reached without a physical examination of the complaint device.Although the device was not evaluated, it is possible that protein deposits inside the valve affected the function of the progav®2.0.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hydrocephalus therapy (hc-therapy) by shunt implants.Manufacturing defects at the time of release have been excluded.The shunt system met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.

Event Description

It was reported that a progav2.0 valve (part # fx410t) was implanted during a procedure performed on (b)(6) 2017.According to the complainant, a blockage of the valve was suspected and the shunt system was believed to be operating in underdrainage.The patient underwent a revision procedure on (b)(6) 2021.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: (b)(6) years.Height: 160 centimeters (cm).Weight: (b)(6) kilograms (kg).Gender: unknown.The same patient as #3004721439-2021-00266.

• Brand Name: PROGAV 2.0 VALVE
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12535140
• MDR Text Key: 273475052
• Report Number: 3004721439-2021-00267
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 04041906136529
• UDI-Public: 4041906136529
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K161853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2020
• Device Model Number: FX410T
• Device Catalogue Number: FX410T
• Device Lot Number: 20028403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/28/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 70