MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-04-17 for EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE 9600TFX29A manufactured by Edwards Lifesciences.
[142231442]
Udi reference number: (b)(4). Investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[142231443]
As reported through the implant patient registry, nine days post deployment of a 29mm sapien 3 valve in the mitral position, the patient was implanted with a second 29mm sapien 3 valve.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2015691-2019-01344 |
MDR Report Key | 8522848 |
Report Source | COMPANY REPRESENTATIVE,HEALTH |
Date Received | 2019-04-17 |
Date of Report | 2019-03-27 |
Date of Event | 2019-02-22 |
Date Mfgr Received | 2019-05-24 |
Device Manufacturer Date | 2018-12-04 |
Date Added to Maude | 2019-04-17 |
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 | RN 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 | ONE 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 | 3 |
Brand Name | EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE |
Generic Name | PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED |
Product Code | NPU |
Date Received | 2019-04-17 |
Model Number | 9600TFX29A |
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 | ONE EDWARDS WAY IRVINE CA 92614 US 92614 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2019-04-17 |