MAUDE Adverse Event Report: VALVE IN CARTRIDGE, 7MM; SPIRATION VALVE

Model Number SVS-V7-00

Device Problem Difficult to Remove (1528)

Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888)

Event Date 07/01/2022

Event Type  Death  

Event Description

Patient was treated for emphysema.Spiration valves were placed.Patient clinically worse post procedure and was optimized medically.Patient was found to have persistent lul expansion.Repeat bronchoscopy was performed approximately one month post procedure.Clinician indicated not all valves visualized consistent with migration and valve was replaced.Patient continued to worsen clinically.Decision was made to remove valves.Approximately 5 months post procedure, the decision was made to remove valves due to patient clinical regression.Lingular segmental valve was removed without incident.Anterior segmental valve (svs-v7-00) with significant granulation tissue was also removed.Aggressive attempts at removal resulted in significant airway bleeding leading to airway compromise and subsequent cardiac arrest requiring extracorporeal support.Patient passed away.

Manufacturer Narrative

Physician reported the event was not device related but technique related.Device not returned to manufacturer.

• Brand Name: VALVE IN CARTRIDGE, 7MM
• Type of Device: SPIRATION VALVE
• Manufacturer Contact: sophia rubalcaba ; 6675 185th ave ne; redmond, WA 98052 ; 4256365470
• MDR Report Key: 15176522
• MDR Text Key: 297352114
• Report Number: 3004450998-2022-00013
• Device Sequence Number: 1
• Product Code: NJK
• UDI-Device Identifier: 00896506002279
• UDI-Public: 896506002279
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PMA P180007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SVS-V7-00
• 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: 07/07/2022
• 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; Hospitalization; Death