MAUDE Adverse Event Report: SPIRATION VALVE IN CARTRIDGE, 9MM; SPIRATION VALVE

Model Number SVS-V9-00

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Hemorrhage, Cerebral (1889)

Event Type  Death  

Manufacturer Narrative

As noted above, the physician indicated that the patient death was definitely not related to the valve.But because he said it could possible be related to the bronchoscopic lung volume reduction (blvr) procedure, spiration has chosen to report this event.Note that the product code for this use of the spiration valve is njk, pulmonary valve to improve lung function in patients with emphysema.Device not returned; ae not dev related.

Event Description

A (b)(6) year old female with advanced emphysema had three valves placed ¿ two 9mm and one 7mm.The patient had a history of chronic cardiomyopathy, systolic heart failure, atrial flutter, cad and tia in the past without any residual deficits.She had severe but stable right internal carotid artery occlusion and disease.Patient was evaluated by her cardiologist and had a workup prior to procedure that included a rhc and stress tests plus echo and deemed ok for procedure.She was on plavix which was held for the procedure and only after clearance from her cardiologist that we could safely hold it before and after the procedure.She had afib the 2nd day post-procedure that was rate controlled with lopressor.She was placed back on plavix and asa with follow-up by her cardiologist 3 days post-procedure.Per cardiologist she felt much better breathing wise and looked terrific and was going to do a tee and elective cardioversion.He wanted to add another oral anticoagulant to her regime.Dr.(b)(6)¿s office learned three days later (6 days post-procedure) that the patient had a stroke and died.Dr.(b)(6) said the death was definitely not related to the valve but that it could possibly be related to the bronchoscopy procedure.

• Brand Name: VALVE IN CARTRIDGE, 9MM
• Type of Device: SPIRATION VALVE
• Manufacturer (Section D): SPIRATION; 6675 185th avenue ne,; redmond WA 98052
• Manufacturer Contact: cyndy adams ; 6675 185th ave ne; redmond, WA 98052 ; 4256365450
• MDR Report Key: 8622043
• MDR Text Key: 145474268
• Report Number: 3004450998-2019-00006
• Device Sequence Number: 1
• Product Code: OAZ
• UDI-Device Identifier: 00896506002309
• UDI-Public: 00896506002309
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PMA P180007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SVS-V9-00
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/18/2019
• 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): Death