MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-02 for VALVE IN CARTRIDGE, 6MM HUS-V6 manufactured by Spiration.
[122447935]
Patient had 3 valves placed on (b)(6) 2018 for pal following lobectomy. On (b)(6) 2018 patient was admitted for pneumonia. Physician stated that the pneumonia was likely unrelated to the valves, however, he could not say for sure. Pneumonia is listed in the patient brochure as a potential risk related to either the procedure or the valves. Site reports that the patient was discharged 4 days after admission for pneumonia with valves still in place. The pneumonia was not fully resolved when the patient was discharged, however it had resolved by the time the patient came back in to the clinic on (b)(6) 2018. The conclusions above are based on a review of the device history files and the dfmea.
Patient Sequence No: 1, Text Type: N, H10
[122447936]
Patient admitted to (b)(6) on (b)(6) 2018 for pneumonia. In discussion with dr. (b)(6), pneumonia covers entire right side of the lung, the same side where the valves were placed. Patient started on iv antibiotics. Patient is still admitted and is continuing on antibiotics.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004450998-2018-00006 |
| MDR Report Key | 7928768 |
| Date Received | 2018-10-02 |
| Date of Report | 2018-10-02 |
| Date of Event | 2018-09-08 |
| Date Mfgr Received | 2018-09-10 |
| Device Manufacturer Date | 2018-01-04 |
| Date Added to Maude | 2018-10-02 |
| 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 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, 6MM |
| Generic Name | SPIRATION VALVE |
| Product Code | OAZ |
| Date Received | 2018-10-02 |
| Model Number | HUS-V6 |
| Lot Number | W02612-01 |
| 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. Hospitalization; 2. Required No Informationntervention | 2018-10-02 |