MAUDE Adverse Event Report: GYRUS ACMI, INC. SPIRATION VALVE; SPIRATION VALVE SYSTEM

Model Number UNKNOWN

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

Patient Problem Cardiac Arrest (1762)

Event Date 08/30/2020

Event Type  Death  

Manufacturer Narrative

Event occurred three days after placement of the commercial valves.No valve information (name, model, lot number, or number of valves placed), including valve status (i.E.Whether valves were removed) was available at the time of this report.Investigator assessment per study protocol indicated device relationship was ¿probably not related¿ and procedure relationship as ¿definitely not related¿.Device disposition unknown.

Event Description

An (b)(6) study patient, with spiration valves placed approximately 6 years prior to the reported event, had elective bronchial valve placement surgery while still enrolled in the emprove study.Subject was scheduled for release three days post elective valve placement procedure, however patient experienced cardiac arrest and was re-admitted.Patient experienced a second cardiac arrest three days later and patient died.

• Brand Name: SPIRATION VALVE
• Type of Device: SPIRATION VALVE SYSTEM
• 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: 11572731
• MDR Text Key: 242377636
• Report Number: 3004450998-2021-00013
• Device Sequence Number: 1
• Product Code: NJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180007
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• 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: 03/05/2021
• 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): Death