MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-01 for VALVE IN CARTRIDGE, SPIRATION VALVE SYSTEM UNKNOWN manufactured by Spiration.
[143799590]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004450998-2019-00005 |
| MDR Report Key | 8571510 |
| Date Received | 2019-05-01 |
| Date of Report | 2019-05-01 |
| Date Mfgr Received | 2019-04-03 |
| Date Added to Maude | 2019-05-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| 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, SPIRATION VALVE SYSTEM |
| Generic Name | SPIRATION VALVE SYSTEM |
| Product Code | OAZ |
| Date Received | 2019-05-01 |
| Model Number | UNKNOWN |
| 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. Other | 2019-05-01 |