MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-29 for IMPELLA RP 004333 manufactured by Abiomed, Inc..
[29815204]
Patient Sequence No: 1, Text Type: N, H10
[29815225]
A week after femoral insertion of impella rp (right percutaneous) device, the patient started to have high purge pressures and corresponding decrease in flow suggestive of impending device failure. The impella circulatory blood support currently ran at p7 (3 lpm) but with improved pulsatility. Some increase in ectopy on current pressors. As impella decreased to p2 (1 lpm) with mild decrease in lvad (left ventricular assist device) pulsatility and the hmii (heartmate ii) heart pump decreased to 9000 rpm, physician decided to proceed with removal of device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5187652 |
| MDR Report Key | 5187652 |
| Date Received | 2015-10-29 |
| Date of Report | 2015-10-11 |
| Date of Event | 2015-10-09 |
| Report Date | 2015-10-11 |
| Date Reported to FDA | 2015-10-11 |
| Date Reported to Mfgr | 2015-10-11 |
| Date Added to Maude | 2015-10-29 |
| 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 RP |
| Generic Name | RIGHT VENTRICULAR BYPASS (ASSIST) DEVICE |
| Product Code | OJE |
| Date Received | 2015-10-29 |
| Model Number | 004333 |
| Catalog Number | 004333 |
| Device Expiration Date | 2016-12-31 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| 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 | 2015-10-29 |