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

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.The device history records (dhr) were not able to be reviewed as the lot number was not made available.However, all device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

Event Description

It was reported that a progav 2.0 shuntsystem (part # unknown) was implanted during a procedure performed on an unknown date.According to the complainant, the shunt system experienced an unspecified malfunction.The patient underwent a revision procedure on an unknown date.The complaint device was not available to be returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.

• Brand Name: PROGAV 2.0 SHUNTSYSTEM
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 13721643
• MDR Text Key: 286940557
• Report Number: 2916714-2022-00025
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/10/2022
• Distributor Facility Aware Date: 02/18/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention