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

Model Number 80752025

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

Patient Problem Hydrocephalus (3272)

Event Type  Injury  

Manufacturer Narrative

Manufacturing and quality control data: the progav® was manufactured by a qualified employee in february 2014.Deviations during assembly did not occur.The valve was sterilized by miethke and released for shipment after final inspection.The progav® has a normal pressure range of 0 to 20 cmh2o.The valve was inspected as article (b)(4).All parameters have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specifications.Visual inspection: a deformation of the outer housing of the progav® valve was observed through the visual inspection.The measurement of the plane parallelism could confirm that with a value of -0,050mm the housing membrane is clearly outside tolerance (0 ± 0.02 mm).The progav® valve housing was subsequently measured and confirmed/indicated the presence of a deformation.The housing deformation measured at - 0.000 mm, outside the tolerance of 0 ± 0.02 mm.Permeability test: a permeability test has shown that the valve is permeable.Adjustment test: the progav® was tested and is not adjustable throughout the normal range.Klick force and brake function test: the brake functionality test has shown that the brake function did not operate as expected.The results indicate that the rotor no longer performs as required.Internal inspection: after dismantling of the valve, some deposits were found in progav®.Result: based on our investigation, we are unable to substantiate the claim of non-adjustability.At the time of our investigation, the valve was able to be adjusted to all specified settings.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.The cause of the deformation of the progav® valve and the resultant defect of the rotor could not be determined through our investigation.Significant outside pressure, for example by too much force from the progav® adjustment tool or by a fall or impact to the head of the patient, can 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 (b)(4).No further regulatory actions are required from our point of view.

Event Description

It was reported that a progav valve was implanted during a procedure performed on an unknown date.According to the complainant, the shunt system was believed to be blocked and was difficult to adjust.The patient underwent a revision procedure.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).Height: 138 cm.Weight: (b)(6).Gender: unknown.The same patient as #3004721439-2021-00264.

• Brand Name: PROGAV 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: 12530068
• MDR Text Key: 276401600
• Report Number: 3004721439-2021-00265
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 04041906136499
• UDI-Public: 4041906136499
• 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: 09/24/2021

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: 02/04/2019
• Device Model Number: 80752025
• Device Catalogue Number: 80752025
• Device Lot Number: 20022362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2021
• Initial Date FDA Received: 09/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2014
• 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: 11 YR
• Patient Weight: 31