MAUDE Adverse Event Report: SPIRATION, INC. SPIRATION VALVE SYSTEM, VALVE IN CARTRIDGE; ONE-WAY AIR LEAK VALVE

Model Number REF-HUS-V7

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Low Blood Pressure/ Hypotension (1914); Pain (1994); Dizziness (2194)

Event Date 11/17/2014

Event Type  Injury  

Event Description

Pt 9 had spiration valves placed on (b)(6) 2014 for treatment of pneumothorax due to severe bullous disease.At (b)(6) 2014 follow-up appointment, pt had bad cough (of one-week duration with increasing intensity), wheezing, and chest tightness (stabbing back and chest pain).Due to the severe pain with coughing, low blood pressure, and dizziness, physicians thought it best to admit the pt.On (b)(6) 2014, physician who placed the valves removed them.

Manufacturer Narrative

Spiration reviewed device labeling (instructions for use and pt brochure) and confirmed that: the device was used off-label and the adverse events are anticipated (a long-lasting cough and severe problems that may require medical treatment).Method: reviewed report sent to (b)(4) by physician on (b)(6) 2014, (b)(4) conclusion dated (b)(4) 2014, physician's follow-up report dated (b)(6) 2014, and email communications with site research coordinator.In email dated (b)(6) 2014, it was indicated that physician thought the pt's symptoms were related to the spiration valves.On (b)(4) 2014, the (b)(4) concluded that the adverse event was not an unanticipated problem involving risks to subject or others.

• Brand Name: SPIRATION VALVE SYSTEM, VALVE IN CARTRIDGE
• Type of Device: ONE-WAY AIR LEAK VALVE
• Manufacturer (Section D): SPIRATION, INC.; 6675 185th avenue ne; redmond WA 98052
• Manufacturer Contact: cyndy adams ; 6675 185th avenue ne; redmond, WA 98052 ; 4254971700
• MDR Report Key: 4435568
• MDR Text Key: 5421356
• Report Number: 3004450998-2014-00001
• Device Sequence Number: 1
• Product Code: OAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H060002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2016
• Device Model Number: REF-HUS-V7
• Device Lot Number: W05905-01, W06125-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• 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): Hospitalization
• Patient Age: 54 YR