MAUDE Adverse Event Report: VALVE IN CARTRIDGE, 5MM; SPIRATION VALVE 5MM

Model Number	SVS-V5-00
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	09/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Spiration valve model number(s), the total number of devices placed and the treatment indication could not be determined.Attempts were made to obtain healthcare provider information in order to investigate the patient reported event; however, no healthcare provider information was provided.
Event or Problem Description
Patient contacted gyrus acmi, inc.One month after placement of spiration valve(s).Patient indicated he experienced post-procedural complications and was hospitalized for twelve days.After discharge from hospital he indicated that he was experiencing weakening of legs, shortness of breath, requiring him to sit down to catch his breath after walking.Patient indicated he had contacted his physician and was advised to go to the emergency room.No other information available.

• Brand Name: VALVE IN CARTRIDGE, 5MM
• Common Device Name: SPIRATION VALVE 5MM
• MDR Report Key: 10914342
• Report Number: 3004450998-2020-00039
• Device Sequence Number: 11449189
• Product Code: NJK
• UDI-Device Identifier: 00896506002286
• UDI-Public: 00896506002286
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SVS-V5-00
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 11/27/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other