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 |