MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-03 for SAPIEN 3 TRANSCATHETER HEART VALVE 9600TFX 9600TFX23A manufactured by Edwards Lifesciences Llc.
[144237576]
During a transcatheter pulmonary valve replacement, the balloon of edwards sapien 3 device failed on deployment leaving the valve partially deployed. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW5086375 |
MDR Report Key | 8582318 |
Date Received | 2019-05-03 |
Date of Report | 2019-05-01 |
Date of Event | 2019-04-16 |
Date Added to Maude | 2019-05-06 |
Event Key | 0 |
Report Source Code | Voluntary report |
Manufacturer Link | N |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Reporter Occupation | RISK MANAGER |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Brand Name | SAPIEN 3 TRANSCATHETER HEART VALVE |
Generic Name | PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED |
Product Code | NPU |
Date Received | 2019-05-03 |
Returned To Mfg | 2019-04-16 |
Model Number | 9600TFX |
Catalog Number | 9600TFX23A |
Lot Number | (17)200730 |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Eval'ed by Mfgr | I |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | EDWARDS LIFESCIENCES LLC |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2019-05-03 |