MAUDE Adverse Event Report: GYRUS ACMI, INC. VALVE IN CARTRIDGE, 9MM; SPIRATION VALVE

Model Number	HUS-V9
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	11/04/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Spiration valves were used to treat bronchopleural fistula.This is an off-label use.Adverse event of bradycardia and hypoxia resolved once valves were removed.Device not returned to manufacturer.
Event or Problem Description
Olympus received a report from user facility stating a patient admitted with covid was experiencing air leaks from both of his chest tubes suggesting bronchopleural fistula.The patient was transferred to another facility for an endobronchial valve placement.On (b)(6) 2021 three spiration valves were placed for the treatment of the bronchopleural fistula.Treatment was unsuccessful as patient became bradycardic and hypoxic.Valves were removed and the bradycardia and hypoxia resolved.On (b)(6) 2021 the patient developed hypotension and bradycardia and went into cardiac arrest.Cardiopulmonary resuscitation was started and patient achieved return of spontaneous circulation, though continued to arrest several more times despite full medical resuscitation.The patient passed away several minutes later after experiencing another cardiac arrest.

• Brand Name: VALVE IN CARTRIDGE, 9MM
• Common Device Name: SPIRATION VALVE
• Manufacturer (Section D): GYRUS ACMI, INC.; 6675 185th ave. ne; redmond WA 98052
• Manufacturer Contact: sophia rubalcaba ; 6675 185th ave ne; redmond, WA 98052 ; 4256365470
• MDR Report Key: 15621353
• Report Number: 3004450998-2022-00015
• Device Sequence Number: 15049356
• Product Code: OAZ
• UDI-Device Identifier: 00896506002200
• UDI-Public: 00896506002200
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: HDE H060002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/17/2022

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: HUS-V9
• 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: 09/20/2022
• Initial Report FDA Received Date: 10/18/2022
• 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: Death
• Patient Sex: Unknown