MAUDE Adverse Event Report: GYRUS ACMI, INC. SPIRATION VALVE SYSTEM; VALVE, PULMONARY

Model Number	SVS-C26N-06
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Deployment catheter for pulmonary valve placement failed to attach to two different spiration pulmonary valves, rendering them unable to be used for medical purposes.

• Brand Name: SPIRATION VALVE SYSTEM
• Common Device Name: VALVE, PULMONARY
• Manufacturer (Section D): GYRUS ACMI, INC.; 6675 185th avenue ne; redmond WA 98052
• MDR Report Key: 20609169
• Report Number: 20609169
• Device Sequence Number: 7930080
• Product Code: NJK
• UDI-Device Identifier: 00896506002316
• UDI-Public: (01)00896506002316(17)261130(10)WS450692
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2024
• Report Date (Section F): 09/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SVS-C26N-06
• Device Lot Number: WS450692
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/05/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/05/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Date Report Sent to FDA: 09/11/2024