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

Model Number HUS-V7

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fistula (1862); Sepsis (2067)

Event Type  Death  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 306359909
• Report Number: 3004450998-2022-00030
• Device Sequence Number: 1
• Product Code: OAZ
• 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: Other
• Type of Report: Initial
• Report Date: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HUS-V7
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2022
• 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): Death; Hospitalization