MAUDE Adverse Event Report: GYRUS ACMI, INC. VALVE IN CARTRIDGE, 7MM; SPIRATION VALVE

Model Number	HUS-V7
Health Effect - Clinical Codes	Fistula (1862); Sepsis (2067)
Type of Reportable Event	Death
Event or Problem Description
Patient presented with acute dyspnea due to spontaneous right tension pneumothorax requiring urgent chest tube placement.Treatment was complicated by persistent air leak (pal) and pneumonia.Patient underwent right video-assisted thorascopic surgery (vats).What appeared to be a right middle lobe alveolar-pleural fistula was identified.Attempts to treat with sealants were unsuccessful.Endobronchial valves (manufacturer brand not known) were placed in treatment of air leak.Placement of an intrabronchial valve (ibv) in the rml bronchus was completed.The air leak significantly decreased, then resolved within two days.One month later, sepsis and a pleuro-cutaneous fistula with air leak developed at the site of the previous chest tube insertion.A chest tube was placed followed by an eloesser window procedure to drain the infected pleural space.The patient remained hospitalized for about two months and expired from septic and cardiac complications.
Additional Manufacturer Narrative
The referenced article was discovered from literature review activities."revelo a, keshishyan s, epelbaum o,yaghoubian s, delorenzo l, chandy d, carroll f, paul l,harris k.Diagnostic and therapeutic challenges in managing persistent air leaks.J thorac dis 2018;10(1):522-528.Doi: 10.21037/jtd.2018.01.43".The article was published in 2018, however dates of valve placement and adverse event were not provided.Device not returned to manufacturer.

• Brand Name: VALVE IN CARTRIDGE, 7MM
• Common Device Name: SPIRATION VALVE
• Manufacturer (Section D): GYRUS ACMI, INC.; 6675 185th ave ne; redmond WA 98052
• Manufacturer (Section G): GYRUS ACMI, INC.; 6675 185th ave ne; redmond WA 98052
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16069834
• Report Number: 3004450998-2022-00030
• Device Sequence Number: 6234520
• Product Code: OAZ
• UDI-Device Identifier: 00896506002101
• UDI-Public: 00896506002101
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 12/29/2022

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-V7
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 12/29/2022
• 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: Death; Hospitalization
• Patient Sex: Unknown