MAUDE Adverse Event Report: VALVE IN CARTRIDGE, 6MM; SPIRATION VALVE

Model Number	HUS-V6
Health Effect - Clinical Code	Pneumonia (2011)
Date of Event	09/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient had 3 valves placed on (b)(6) 2018 for pal following lobectomy.On (b)(6) 2018 patient was admitted for pneumonia.Physician stated that the pneumonia was likely unrelated to the valves, however, he could not say for sure.Pneumonia is listed in the patient brochure as a potential risk related to either the procedure or the valves.Site reports that the patient was discharged 4 days after admission for pneumonia with valves still in place.The pneumonia was not fully resolved when the patient was discharged, however it had resolved by the time the patient came back in to the clinic on (b)(6) 2018.The conclusions above are based on a review of the device history files and the dfmea.
Event or Problem Description
Patient admitted to (b)(6) on (b)(6) 2018 for pneumonia.In discussion with dr.(b)(6), pneumonia covers entire right side of the lung, the same side where the valves were placed.Patient started on iv antibiotics.Patient is still admitted and is continuing on antibiotics.

• Brand Name: VALVE IN CARTRIDGE, 6MM
• Common Device Name: SPIRATION VALVE
• MDR Report Key: 7928768
• Report Number: 3004450998-2018-00006
• Device Sequence Number: 1798154
• Product Code: OAZ
• UDI-Device Identifier: 00896506002095
• UDI-Public: 00896506002095
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: HDE H060002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/02/2018

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-V6
• Device Lot Number: W02612-01
• 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: 09/10/2018
• Initial Report FDA Received Date: 10/02/2018
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2018
• 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: Hospitalization; Required Intervention