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

Model Number HUS-V9

Device Problem Migration (4003)

Patient Problems Hypoxia (1918); Pneumothorax (2012); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 290151007
• Report Number: 3004450998-2022-00007
• 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: Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2022
• 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): Required Intervention