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

Model Number	HUS-V9
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Hypoxia (1918); Pneumothorax (2012); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Publication did not specify valve model or valve sizes.Author of publication was contacted for additional information.No additional information available at the time of this report.It is not known if the valves were removed from the patient after transfer for lung transplant evaluation.Device not returned to manufacturer.
Event or Problem Description
Valve migration discovered from a clinical literature search taken from: https://www.Atsjournals.Org/doi/abs/10.1164/ajrccm-conference.2021.203.1_meetingabstracts.A2193 riggle et al, bilateral endobronchial valves: an option for severe bilateral persistent air leak; american journal of respiratory and critical care medicine 2021;203:a2193.The article discusses the off label use of aspiration endobronchial valves to treat persistent bronchopleural fistulas (bpf) in an unstable patient.Large bilateral pals with residual pneumothoraxes did not resolve after placement of bilateral thoracostomy tubes.Venovenous ecmo was initiated due to hypercapnia and hypoxia on maximal ventilator settings.To promote pleurodesis with continued large bilateral pal, aspiration ibvs were deployed to rb 1, rb 2, rb 3, lb 1-3, and lb 4-5.Blood patch pleurodesis was also performed bilaterally.Ibvs at rb 3 and lb 4-5 were subsequently found to have migrated and were replaced.No additional information was provided regarding migration of the two valves.Patient was eventually transferred on ecmo for lung transplant evaluation due to severe irreversible pulmonary parenchymal disease.

• 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: 14215138
• Report Number: 3004450998-2022-00007
• Device Sequence Number: 5479705
• Product Code: OAZ
• UDI-Device Identifier: 00896506002200
• UDI-Public: 00896506002200
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: 03/28/2022
• 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: Required Intervention
• Patient Sex: Unknown