N
Patient 1
MAUDE MDR 6228926
- MDR report key
- 6228926
- Report number
- 6228926
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-11-08
- Date received
- 2017-01-06
- Adverse event
- 3
- Product problem
- 0
- 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 CP LMR | TEMPORARY CARDIAC SUPPORT BLOOD PUMP | ABIOMED, INC. | PBL | R | * |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-01-06 | 0 | 1. H; 2. R |
Event Narratives#
D
Patient 1
PATIENT PRESENTED FOR A LEFT VENTRICULAR DESCENDING CORONARY ARTERY (LAD) INTERVENTION, COMPLICATED BY A LEFT MAIN DISSECTION. AN IMPELLA DEVICE WAS IMPLANTED, THE PATIENT SUSTAINED A PERFORATION TO THE LEFT VENTRICLE REQUIRING SURGERY TO REPAIR THE PERFORATION. PLEASE NOTE: I WILL OBTAIN MORE DETAILS ABOUT THE SPECIFIC DEVICE, I DO NOT HAVE ACCESS TO THIS INFORMATION AT THE TIME I AM ENTERING THIS REPORT, BUT WILL OBTAIN. THEREFORE, THE DEVICE SPECIFIC INFORMATION PROVIDED WILL BE LIMITED AT THIS TIME.