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

Model Number FV410T

Device Problem Mechanical Problem (1384)

Patient Problems Failure of Implant (1924); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

(b)(4).When additional information is received, a follow up report will be submitted.

Event Description

It was reported post-operative maladjustment.There was no patient information, and no information regarding implantation date or explantation date provided.Additional information has been requested, however, not yet received.

Manufacturer Narrative

Aesculap inc.(importer, registration no.2916714) is submitting this report on behalf of christoph miethke gmbh & co.Kg (manufacturer, registration no.3004721439).Exemption number: e2017044 investigation: visual inspection: a deformation of the outer housing of the progav valve was observed through the visual inspection.The progav valve housing was subsequently measured and confirmed the presence of a deformation.The housing deformation measured at -0.134mm, outside the tolerance of 0 ± 0.02mm.Permeability test a permeability test has shown that the progav valve is permeable.Adjustment test the progav valve was tested and is adjustable to all specified pressures.However the force required to perform the adjustment was significantly lower than expected.Breaking 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.Results first we performed a visual information of the progav valve.A deformation of the outer housing of the progav valve was observed through the visual inspection.The deformation was confirmed through a measurement of the parallelity of the valve housing.Next we tested the permeability and adjustability of the valve, as well as the brake functionality and brake force.The progav valve was permeable.However, while it was able to be easily adjusted to all pressure settings, the normal resistance provided through the brake function was missing, indicating a compromise of the braking function.Finally, we have dismantled the valve.Inside the valve we have found build-up of substances (likely protein).Based on our investigation, we are a le to partially confirm the claim of non-adjustability.While the valve is easily adjustable, due to the compromised brake functionality it does not hold the set pressure.This is likely due to the observed deformation of the progav housing.The cause of the deformation of the progav valve and the resultant defect of the roto could not be determined through our investigation.Significant outside pressure, for example by too much formce form 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 gmbh & co.Kg.

• Brand Name: PROGAV VALVE
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 8592732
• MDR Text Key: 145012220
• Report Number: 3004721439-2019-00101
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K103003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: FV410T
• Device Catalogue Number: FV410T
• Device Lot Number: 20027140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Distributor Facility Aware Date: 04/26/2019
• Date Manufacturer Received: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1