MAUDE Adverse Event Report: SPIRATION VALVE IN CARTRIDGE, SPIRATION VALVE SYSTEM

Model Number UNKNOWN

Device Problems Gas/Air Leak (2946); Migration (4003)

Patient Problems Unspecified Infection (1930); Pneumonia (2011)

Event Type  Injury  

Event Description

Based on a letter to the editor in journal of bronchology & interventional pulmonology (an unusual complication of long-term endobronchial valves placed for persistent air leak, journal of bronchology & interventional pulmonology 24 (2): e18¿20), spiration became aware that two of three valves placed in a patient for a prolonged air leak post-lobectomy appeared to have migrated into the pleural space.According to the letter, the valves were placed under the hde and the air leak resolved, but the valves were not removed within 6 weeks as specified in hde instructions for use.When seen 2 years later by the physicians who submitted the letter, the valves were still in place and they report that the patient had recurring pseudomonas aeruginosa pneumonia requiring iv antibiotics for the two years following valve placement.Two of the three valves were removed and cultured, yielding pseudomonas aeruginosa.The authors indicate that while the infection is not necessarily due to the valves, it is possibly related to them.The third valve could not be retrieved.After removal of the two valves, the patient has done well without further antibiotics.

• Brand Name: VALVE IN CARTRIDGE, SPIRATION VALVE SYSTEM
• Type of Device: SPIRATION VALVE SYSTEM
• Manufacturer (Section D): SPIRATION; 6675 185th avenue ne; redmond WA 98052
• MDR Report Key: 8571510
• MDR Text Key: 143799590
• Report Number: 3004450998-2019-00005
• Device Sequence Number: 1
• Product Code: OAZ
• Combination Product (y/n): N
• PMA/PMN Number: H060002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2019
• 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): Other