MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-11-20 for IMPELLA RP 0046-0019 manufactured by Abiomed Europe Gmbh.
[92548359]
Neither the product nor data logs were returned for analysis. The manufacturing review found no other complaints against this lot of impella rp pumps. Without product or data logs, no root cause of the bleed could be determined. The failure mode will be trended and monitored. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[92548360]
A (b)(6) female patient was admitted with right heart failure post pulmonary embolism. An impella rp was placed on (b)(6), in conjunction with the ekos thrombolysis system. On the following day, (b)(6), the abiomed field representative was notified that the rp was explanted due to bleeding. The representative was told there was bleeding around the sheath at the access site. The hospital did not retain the pump or sheath for analysis. There was no need for intervention in the form of blood product replacement or vascular repair. The patient was noted to be stable post rp explant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2017-00107 |
| MDR Report Key | 7046303 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-11-20 |
| Date of Report | 2017-11-07 |
| Date of Event | 2017-10-03 |
| Date Mfgr Received | 2017-11-07 |
| Device Manufacturer Date | 2017-06-30 |
| Date Added to Maude | 2017-11-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MR. RALPH BARISANO |
| Manufacturer Street | 22 CHERRY HILL DRIVE |
| Manufacturer City | DANVERS MA 01923 |
| Manufacturer Country | US |
| Manufacturer Postal | 01923 |
| Manufacturer Phone | 9786461400 |
| Manufacturer G1 | ABIOMED INC. |
| Manufacturer Street | 22 CHERRY HILL DRIVE |
| Manufacturer City | DANVERS MA 01923 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01923 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPELLA RP |
| Generic Name | RIGHT VENTRICLULAR BYPASS ASSIST DEVICE |
| Product Code | PYX |
| Date Received | 2017-11-20 |
| Model Number | IMPELLA RP |
| Catalog Number | 0046-0019 |
| Lot Number | 1289373 |
| Device Expiration Date | 2019-05-31 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABIOMED EUROPE GMBH |
| Manufacturer Address | NEUENHOFER WEG 3 AACHEN, 52074 GM 52074 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2017-11-20 |