MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-08 for IMPELLA RP 0042-000-US manufactured by Abiomed, Inc..
[49088259]
Patient Sequence No: 1, Text Type: N, H10
[49088260]
Abiomed impella device inserted about three days ago in cardiac cath lab at our hospital for decompensated chf and severe mitral valve regurgitation as patient not responsive to medical management after myocardial infarction (mi). Ejection fraction (ef) 10-15% and cardiogenic shock. On removal in operating room, clot found in device. Device failed prior to arrival to operating room and trouble-shooting with abiomed not successful, leading to need for device removal and placement of new rvad.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5778311 |
| MDR Report Key | 5778311 |
| Date Received | 2016-07-08 |
| Date of Report | 2016-06-28 |
| Date of Event | 2016-06-27 |
| Report Date | 2016-06-28 |
| Date Reported to FDA | 2016-06-28 |
| Date Reported to Mfgr | 2016-06-28 |
| Date Added to Maude | 2016-07-08 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| 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 RP |
| Generic Name | RIGHT VENTRICULAR BYPASS (ASSIST) DEVICE |
| Product Code | OJE |
| Date Received | 2016-07-08 |
| Catalog Number | 0042-000-US |
| Device Availability | Y |
| Device Age | 3 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABIOMED, INC. |
| Manufacturer Address | 22 CHERRY HILL DRIVE DANVERS MA 01923 US 01923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-08 |