SPIRATION INTRABRONCHIAL VALVE HUS-V7

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-20 for SPIRATION INTRABRONCHIAL VALVE HUS-V7 manufactured by Spiration.

Event Text Entries

[55702742] The patient is a (b)(6) year old gentleman with a history of severe upper lobs emphysema and multiple secondary spontaneous right sided pneumothoraces. In (b)(6) of 2015, the patient underwent video-assisted thoracoscopy for treatment of a right sided pneumothorax. Unfortunately, on (b)(6) 2015 the pneumothorax recurred and he was admitted. Cardiothoracic surgery was consulted but recommended conservative measures. Subsequently, i was consulted for consideration of endobronchial valve placement. We waited an additional two weeks but unfortunately the leak did not close and the patient could not tolerate water seal, which would have allowed placement of a heimlich valve. Given that there were no other good options and following a thorough discussion and informed consent, the decision was made to proceed with endobronchial valve placement. Two valves were placed on (b)(6) 2015, one in the tracheal bronchus (a right sided apical airway that comes off the trachea directly) and another in the apical segment of the right upper lobe. This procedure was uncomplicated and successful, and on (b)(6) 2015 we were able to remove the chest tube. I subsequently evaluated the patient in follow up several times over the next year. On each occasion we had a discussion around the risks and benefits of valve removal. The patient preferred to leave them in place due to the risk of an again recurrent pneumothorax. On (b)(6) 2016, i performed a surveillance bronchoscopy to evaluate for any possible problems with the valve. Unfortunately we identified that the valve in the tracheal bronchus was now covered in granulation tissues. I thus brought the patient to the operating room to remove the valves. We removed the overlying granulation tissue and removed the valve in the tracheal bronchus via the removal rod without difficulty. On inspection of the valve after removal we noted two missing anchor rods. Ct scan confirmed these were still in the tracheal bronchus. Diagnosis or reason for use: air leak and pneumothorax despite standard therapy. Is the product compounded: no. Is the product over the counter: no.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5065015
• MDR Report Key: 5976402
• Date Received: 2016-09-20
• Date of Report: 2016-09-20
• Date of Event: 2016-09-13
• Date Added to Maude: 2016-09-26
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: SPIRATION INTRABRONCHIAL VALVE
• Generic Name: ENDOBRONCHIAL VALVE
• Product Code: OAZ
• Date Received: 2016-09-20
• Returned To Mfg: 2016-09-12
• Model Number: HUS-V7
• Lot Number: W00600-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SPIRATION
• Manufacturer Address: REDMOND WA US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2016-09-20