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

Model Number HUS-V9

Device Problem Gas/Air Leak (2946)

Patient Problem Low Oxygen Saturation (2477)

Event Date 11/04/2021

Event Type  Death  

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 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
• Type of Device: 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
• MDR Text Key: 301893949
• Report Number: 3004450998-2022-00015
• Device Sequence Number: 1
• Product Code: OAZ
• UDI-Device Identifier: 00896506002200
• UDI-Public: 00896506002200
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: HDE H060002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HUS-V9
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death