MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROSA WITH PROGAV 2.0; PREVIOUSLY REPORTED

Model Number FX992T

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 06/02/2020

Event Type  Injury  

Manufacturer Narrative

If follow-up information/evaluation results are received, a supplemental report will be provided.

Event Description

It was reported that there was an issue with a prosa with progav 2.0 shunt system.The reporter indicated that there was possibly an occlusion.The valve was initially implanted in 2018.The ventricular catheter had been repositioned about 1 week ago.The patient "did better" but neurosurgeon wanted to move it to the left side.The valve was explanted and replaced with a newer version of the same product.Additional information has been requested.

Manufacturer Narrative

An investigation was not possible because no product was send for investigation.It is possible that protein deposits inside the valves affect the function of the shuntsystem and have led to a blockage of the prosa valve.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.However, we cannot finally clarify what influenced the blockage, as this would require an examination of the valve.

Event Description

No updates.

• Brand Name: PROSA WITH PROGAV 2.0
• Type of Device: PREVIOUSLY REPORTED
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 10167355
• MDR Text Key: 199908789
• Report Number: 2916714-2020-00190
• 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: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FX992T
• Device Catalogue Number: FX992T
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/09/2020
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention