MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-19 for VALVE IN CARTRIDGE, 7MM HUS-V7 manufactured by Spiration.
[87641933]
Based on feedback from spiration's medical monitors, who both concluded that even if the anchor pieces remained in the patient, it would be unlikely to lead to a serious adverse event. This event was originally determined to be non-mdr reportable. It was however reported in spiration's 2016 annual report to (b)(4). On august 1, 2017, in response to spiration's annual report (reference (b)(4)) the fda indicated that they thought that a valve fracture should be reported as an mdr. Spiration has agreed to report this occurrence as well as any others that may occur in the future.
Patient Sequence No: 1, Text Type: N, H10
[87641934]
Two valve anchors were separated from the valve - after removing valve, and upon examining the airway, physician noted two anchors remaining in the patient. He removed the anchors; there were no adverse events.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004450998-2017-00003 |
| MDR Report Key | 6877208 |
| Date Received | 2017-09-19 |
| Date of Report | 2017-09-19 |
| Date of Event | 2016-06-29 |
| Date Mfgr Received | 2016-06-29 |
| Date Added to Maude | 2017-09-19 |
| 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 | 425636-545 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VALVE IN CARTRIDGE, 7MM |
| Generic Name | SPIRATION VALVE |
| Product Code | OAZ |
| Date Received | 2017-09-19 |
| Model Number | HUS-V7 |
| Lot Number | W00886-01 |
| ID Number | 00896506002101 |
| 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 | 2017-09-19 |