MAUDE Adverse Event Report: GYRUS ACMI, INC. VALVE IN CARTRIDGE, 6MM; SPIRATION VALVE

Model Number	SVS-V6-00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Respiratory Insufficiency (4462)
Date of Event	04/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A total of four valves (2x svs-v9-00, 1x svs-v7-00, 1xsvs-v6-00 were placed in the patient for a total of four related event reports filed separately for the same patient procedure.This is report three of four associated with this event.
Event or Problem Description
A patient participating in the svs post approval study underwent valve placement procedure for the treatment of emphysema on (b)(6) 2024.The physician placed a total of four spiration valves one svs-v9-00 at rb4+rb5, one svs-v7-00 at rb3, one svs-v6-00 at rb1 and one svs-v9-00 at rb2.On (b)(6) 2024, the patient experienced mild copd exacerbation in the valve treated lobe requiring treatment and hospitalization.The copd event was reported to be related to the initial valve placement and procedure.The patient was treated empirically for copd exacerbation with solumedrol, rtc duonebs, and home inhalers.In addition, the patient was empirically treated with cefepime for possible hospital acquired pneumonia.Patient required high-flow nasal canula, gradually hypoxia improved and was weaned back to home with 1-2l nasal canula.On (b)(6) 2024, the patient was discharged with prednisone taper 30 mg every day for 2 days, 20 mg every day for 2 days, then 10 mg every day for 2 days.The patient was re-admitted to the hospital on (b)(6) 2024 for continued treatment of mild copd exacerbation.The physician suspected it was caused by viral upper respiratory infection (uri), although the respiratory viral panel was negative.The patient was treated with duoneb nebulizers, and a higher dose of steroids, 40 mg prednisone daily.There was no evidence of recurrent bacterial infection.Leukocytosis was noted at 15,000.However, there was no consolidation seen on ct scan and the leukocytosis was felt to be due to ongoing steroid use.The patient was released home on (b)(6) 2024 with ongoing prednisone taper.All four valves remained in place.At patient follow-up on (b)(6) 2024, the patient reported she did not experience complete resolution of symptoms from the initial copd exacerbation event; however, she was seen by a pulmonologist on (b)(6) 2024 and at that time was prescribed additional medication azithromycin (zithromax) 250mg for 5 days.The patient reported feeling well after completing the course of treatment.

• Brand Name: VALVE IN CARTRIDGE, 6MM
• 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: 19442069
• Report Number: 3004450998-2024-00019
• Device Sequence Number: 15574940
• Product Code: NJK
• UDI-Device Identifier: 00896506002293
• UDI-Public: 896506002293
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P180007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/31/2024

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: SVS-V6-00
• Device Lot Number: WS152721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2024
• Initial Report FDA Received Date: 06/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2021
• 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: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White