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

Model Number	HUS-V9
Health Effect - Clinical Codes	Bacterial Infection (1735); Pneumonia (2011)
Type of Reportable Event	Serious Injury
Event or Problem Description
Literature complaint related spiration valve system (unknown model) printed inhttps://www.Atsjournals.Org/doi/abs/10.1164/ajrccm-conference.2020.201.1_ meetingabstracts.A3156 marinak l, ahmad k, peterson j, king c, katugaha s, mahajan a, brown a.Endobronchial valves for persistent bronchopleural fistula after pneumothorax in cystic fibrosis: a double edged sword.Conference abstract.American journal of respiratory and critical care medicine a patient with advanced cystic fibrosis undergoing lung transplant evaluation experienced persistent pneumothorax and bronchopleural fistula (bpf) after placement of chest tube to treat pneumothorax.Four spiration valves were placed in the right upper lobe to treat the pneumothorax and bpf.This is an off-label use.Patient experienced persistent airway infection and was treated with antibiotics.When antibiotics were discontinued, patient then developed a fever and leukocytosis.Patient was then treated with iv antibiotics until lung transplant.The patient was discharged from the hospital with endobronchial valves in place and ongoing iv antibiotic therapy.Three months later, the patient underwent a bilateral lung transplant.
Additional Manufacturer Narrative
The publication did not specify valve model numbers or valves sizes.Author of the publication was contacted for additional information.No additional information was available at time of the report.Device not returned to manufacturer.

• Brand Name: VALVE IN CARTRIDGE, 9MM
• Common Device Name: SPIRATION VALVE
• Manufacturer (Section D): GYRUS ACMI, INC; 6675 185th avenue ne; redmond WA 98052
• Manufacturer Contact: sophia rubalcaba ; 6675 185th ave ne; redmond, WA 98052 ; 4256365470
• MDR Report Key: 14214769
• Report Number: 3004450998-2022-00006
• Device Sequence Number: 14518333
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/26/2022

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 04/26/2022
• 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: Hospitalization
• Patient Sex: Unknown