MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-22 for IMPELLA IMPELLA RP US PUMP SET 004334 manufactured by Abiomed, Inc..
[108888443]
Patient Sequence No: 1, Text Type: N, H10
[108888444]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7532873 |
| MDR Report Key | 7532873 |
| Date Received | 2018-05-22 |
| Date of Report | 2018-05-16 |
| Date of Event | 2018-05-10 |
| Report Date | 2018-05-16 |
| Date Reported to FDA | 2018-05-16 |
| Date Reported to Mfgr | 2018-05-16 |
| Date Added to Maude | 2018-05-22 |
| 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 | 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 |
| Generic Name | RIGHT VENTRICULAR BYPASS (ASSIST) DEVICE |
| Product Code | OJE |
| Date Received | 2018-05-22 |
| Model Number | IMPELLA RP US PUMP SET |
| Catalog Number | 004334 |
| Device Expiration Date | 2019-11-30 |
| Device Availability | * |
| 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 | 2018-05-22 |