MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-30 for EDWARDS SAPIEN 3 TRANSCATHETER, 26MM 9600TFX26A manufactured by Edwards Lifesciences.
[125590805]
(b)(4). The investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[125590806]
After implant of a 26mm sapien 3 valve within a pre-existing non-edwards annuloplasty ring in the mitral position, the valve was post-dilated with a truballoon. After post-dilation, the leaflets were not working. A second 26mm sapien 3 valve was implanted with good results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2018-04458 |
| MDR Report Key | 8022272 |
| Date Received | 2018-10-30 |
| Date of Report | 2018-10-08 |
| Date of Event | 2018-10-08 |
| Date Mfgr Received | 2018-11-30 |
| Device Manufacturer Date | 2018-07-16 |
| Date Added to Maude | 2018-10-30 |
| 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 | MS FRANCES PRESTON |
| Manufacturer Street | 1 EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492505190 |
| Manufacturer G1 | EDWARDS LIFESCIENCES LLC |
| Manufacturer Street | 1 EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EDWARDS SAPIEN 3 TRANSCATHETER, 26MM |
| Generic Name | PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED |
| Product Code | NPU |
| Date Received | 2018-10-30 |
| Model Number | 9600TFX26A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES |
| Manufacturer Address | 1 EDWARDS WAY IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-30 |