MAUDE Adverse Event Report: SOPHYSA POLARIS SPV ADJUSTABLE VALVE; POLARIS® SPV ADJUSTABLE VALVE

Model Number SPV

Device Problem Improper Flow or Infusion (2954)

Patient Problems Headache (1880); Hydrocephalus (3272)

Event Date 06/18/2021

Event Type  malfunction  

Event Description

Valve implanted on (b)(6) 2020 to a (b)(6) patient with chronic hydrocephalus.After a (unspecified) malfunction, and an unsuccessful attempt in clinic to adjust the valve, a shunt revision surgery was performed.Valve was disconnected from proximal catheter and flow was evaluated using a manometer.Flow reportedly sluggish.

• Brand Name: POLARIS SPV ADJUSTABLE VALVE
• Type of Device: POLARIS® SPV ADJUSTABLE VALVE
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquêt; orsay, 91400 ; FR 91400
• Manufacturer (Section G): SOPHYSA; rue sophie germain; besançon, 91400 ; FR 91400
• Manufacturer Contact: hanta ranaivoson ; 5 rue guy moquêt; orsay, 91400 ; FR 91400
• MDR Report Key: 12460019
• MDR Text Key: 271034881
• Report Number: 3001587388-2021-21400
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141227
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SPV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2021
• Was Device Evaluated by Manufacturer?: No
• 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: 45 YR