MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS PED.W/SA20 A.PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number FX441T

Device Problem Infusion or Flow Problem (2964)

Patient Problem Hydrocephalus (3272)

Event Date 07/24/2021

Event Type  Death  

Manufacturer Narrative

Additional information/ investigation result will be submitted in a supplemental report.

Event Description

According to the complainant a progav 2.0 shuntsystem has a blockage/under-drainage the patient underwent a revision procedure on (b)(6) 2021.After the operation the patient died.No further product information available.Age: (b)(6).Height: unknown.Weight: unknown.Gender: female.

Manufacturer Narrative

Additional information: b5 investigation: an investigation was not possible because we have not received sample for investigation.According to the clinic, it was sent to us.Unfortunately, we have not received the sample.A request for investigation made at the german post office, was without feedback.The product details (lot, serial number) are also not known to us.However, it is possible that protein deposits inside the valve affect the function of the progav 2.0 shuntsystem.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.

Event Description

Additional information: a patient died after a revision surgery of hypoxic brain damage in the hospital stuttgart.We know through this report that the comatose patient was brought to the hospital stuttgart on (b)(6) 2021.Computed tomography showed a significantly dilated ventricular system.This resulted in a revision of the shunt.The shunt was found barely permeable.The surgeon inform us that the child had a mentally handicap, but was physically normally developed.Further details on the product were not provided to us.We did not received the product for investigation.

• Brand Name: PROGAV 2.0 SYS PED.W/SA20 A.PRECHAMBER
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12546654
• MDR Text Key: 273772977
• Report Number: 3004721439-2021-00256
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 04041906137465
• UDI-Public: 4041906137465
• Combination Product (y/n): N
• PMA/PMN Number: K161853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FX441T
• Device Catalogue Number: FX441T
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 2 YR