MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-12-01 for SPIRATION VALVVE SYSTEM, VALVE IN CARTRIDGE HUS-V6 manufactured by Spiration Inc..
[32707182]
The device have not yet been removed, and there is a chance they will not be returned when they are removed. However, pneumonia is an anticipated device risk, and there is no suspected issue with the function of the device. The following devices are: lot #, model #, exp date, mfg date(sterile date): w05904-01, hus-v6, 09/30/2015, 10/08/2013; w05905-01, hus-v7, 09/30/2016, 10/08/2013; w06001-01, hus-v6, 12/31/2016, 01/14/2014; w06201-01, hus-v6, 04/30/2017, 05/06/2014; w06202-01, hus-v7, 04/30/2017, 05/06/2014.
Patient Sequence No: 1, Text Type: N, H10
[32707183]
The spiration valves were placed (b)(6) 2014 for treatment of emphysema in left lower lobe of an alpha-1 antitrypsin deficiency patient. According to the treating physician, the patient responded well to the treatment physician, the patient responded well to the treatment, achieving significant volume reduction of the target lobe. Treating physician reported to spiration on (b)(6) 2015 that the patient acutely developed necrotizing post-obstructive pneumonia and empyema in the left lower lobe adn that is related to the device. Patient was in hospital for 7 days with chest tube and antibiotics, now home on iv antibiotics. As of december 1, valves not removed, as patient is not yet stable enough to undergo a bronchoscopy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004450998-2015-00001 |
| MDR Report Key | 5266869 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-12-01 |
| Date of Report | 2015-12-01 |
| Date of Event | 2015-11-01 |
| Date Mfgr Received | 2015-11-01 |
| Date Added to Maude | 2015-12-04 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CYNDY ADAMS |
| Manufacturer Street | 6675 185TH AVENUE 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 | 3 |
| Brand Name | SPIRATION VALVVE SYSTEM, VALVE IN CARTRIDGE |
| Generic Name | ONE-WAY AIR LEAK VALVE |
| Product Code | OAZ |
| Date Received | 2015-12-01 |
| Model Number | HUS-V6 |
| Lot Number | W05904-01 |
| Device Expiration Date | 2016-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPIRATION INC. |
| Manufacturer Address | 6675 185TH AVENUE NE REDMOND WA 98052 US 98052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2015-12-01 |