MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-10 for VALVE IN CARTRIDGE, 9MM IBV-V9 manufactured by Spiration.
[97102787]
Clarification of reported description: based on photos sent by reporter, one of the five anchors detached. The detached anchor was removed from patient. There were no adverse events.
Patient Sequence No: 1, Text Type: N, H10
[97102788]
Ibv-v9 spiration valve strut has come off valve causing valve to not function and migrate. Valve removed and kept for inspection. Implant date: (b)(6) 2016, explant date: (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004450998-2018-00002 |
| MDR Report Key | 7180030 |
| Date Received | 2018-01-10 |
| Date of Report | 2018-01-10 |
| Date of Event | 2017-12-13 |
| Date Mfgr Received | 2017-12-13 |
| Date Added to Maude | 2018-01-10 |
| 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, 9MM |
| Product Code | OAZ |
| Date Received | 2018-01-10 |
| Model Number | IBV-V9 |
| Lot Number | W00549-01 |
| ID Number | 00896506002064 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-01-10 |