N
Patient 1
MAUDE MDR 7532873
- MDR report key
- 7532873
- Report number
- 7532873
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-05-10
- Date received
- 2018-05-22
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- U
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | IMPELLA | RIGHT VENTRICULAR BYPASS (ASSIST) DEVICE | ABIOMED, INC. | OJE | IMPELLA RP US PUMP SET | 004334 | R | * |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-05-22 | 0 |
Event Narratives#
D
Patient 1
THE IMPELLA DEVICE "SUCKED UP" A CLOT. "INITIALLY TOLERATED COMING OFF BYPASS BUT THEN ABRUPTLY DETERIORATED SECONDARY TO RIGHT VENTRICULAR ASSIST DEVICE (RVAD) DYSFUNCTION AND RV FAILURE. INO AND ISOPROTERENOL WERE STARTED WITH MINIMAL IMPROVEMENT. THE RP RVAD WAS REMOVED AND THE IMPELLER WAS FOUND TO BE OBSTRUCTED BY THROMBUS.