MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-17 for VALVE IN CARTRIDGE, 9MM SVS-V9-00 manufactured by Spiration.
[145474268]
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.
Patient Sequence No: 1, Text Type: N, H10
[145474269]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004450998-2019-00006 |
| MDR Report Key | 8622043 |
| Date Received | 2019-05-17 |
| Date of Report | 2019-05-17 |
| Date Mfgr Received | 2019-04-18 |
| Date Added to Maude | 2019-05-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CYNDY ADAMS |
| Manufacturer Street | 6675 185TH AVE NE |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4256365450 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VALVE IN CARTRIDGE, 9MM |
| Generic Name | SPIRATION VALVE |
| Product Code | OAZ |
| Date Received | 2019-05-17 |
| Model Number | SVS-V9-00 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPIRATION |
| Manufacturer Address | 6675 185TH AVENUE NE, REDMOND WA 98052 US 98052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-05-17 |