MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-06 for IMPELLA CP LMR manufactured by Abiomed, Inc..
[64057642]
Patient Sequence No: 1, Text Type: N, H10
[64057643]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6228926 |
| MDR Report Key | 6228926 |
| Date Received | 2017-01-06 |
| Date of Report | 2016-11-22 |
| Date of Event | 2016-11-08 |
| Report Date | 2016-11-22 |
| Date Reported to FDA | 2016-11-22 |
| Date Reported to Mfgr | 2016-11-22 |
| Date Added to Maude | 2017-01-06 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| 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 | 3 |
| Brand Name | IMPELLA CP LMR |
| Generic Name | TEMPORARY CARDIAC SUPPORT BLOOD PUMP |
| Product Code | PBL |
| Date Received | 2017-01-06 |
| Device Expiration Date | 2018-09-30 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABIOMED, INC. |
| Manufacturer Address | 22 CHERRY HILL DR. DANVERS MA 01923 US 01923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2017-01-06 |