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

Model Number SVS-V9-00

Device Problem Off-Label Use (1494)

Patient Problem Pneumonia (2011)

Event Type  Injury  

Manufacturer Narrative

Reported event discovered in review of publication ¿utility of functional pneumonectomy by using intrabronchial valves first case series and single center experience¿ published (b)(6) 2021 at (b)(4).The published study was an irb-approved study of (off-label) use of valves to perform bronchoscopic functional pneumectomy (bfp).A single lung transplant patient with hyperinflated native lung underwent bfp.Lot numbers and size numbers were not available.Procedure occurred between june 2018 and august 2019, as noted in the publication.Device not returned to manufacturer.Not removed from patient.

Event Description

Publication reported patient with compromised pulmonary function due to hyperinflated native lung underwent bronchoscopic functional pneumectomy (bfp) with interbronchial valves.Nine spiration valves were placed in an off-label use.Patient subsequently developed lobar pneumonia in the lung where the valves were placed.Patient was treated as an outpatient.Valve removal was not required.

Manufacturer Narrative

Reported event discovered in review of publication ¿utility of functional pneumonectomy by using intrabronchial valves first case series and single center experience¿ published 12/08/2021 at (https://journals.Lww.Com/bronchology/abstract/9000/utility-of-functional-pneumonectomy-by-using.99690.Aspx) authored by joseph c.Keenan, md, roy c.Cho, md, jennifer wong, md, and h.Erhan dincer, md.The published study was an irb-approved study of (off-label) use of valves to perform bronchoscopic functional pneumectomy (bfp).A single lung transplant patient with hyperinflated native lung underwent bfp.Lot numbers and size numbers were not available.Procedure occurred between june 2018 and august 2019, as noted in the publication.Device not returned to manufacturer.Not removed from patient.

Event Description

Publication reported patient with compromised pulmonary function due to hyperinflated native lung underwent bronchoscopic functional pneumectomy (bfp) with interbronchial valves.Nine spiration valves were placed in an off-label use.Patient subsequently developed lobar pneumonia in the lung where the valves were placed.Patient was treated as an outpatient.Valve removal was not required.

• 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: 13170887
• MDR Text Key: 285411579
• Report Number: 3004450998-2022-00005
• Device Sequence Number: 1
• Product Code: NJK
• UDI-Device Identifier: 00896506002309
• UDI-Public: 896506002309
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SVS-V9-00
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/09/2021
• 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