MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2020-02-19 for IMPELLA 5.0 IMPELLA 5.0 AIC PUMP SET US 05062 manufactured by Abiomed Europe Gmbh.
[182569107]
The investigation into the presumed hemolysis is on-going at this time. The medical facility has not yet released the pump for analysis and hemolysis testing. Upon completion of the investigation a final report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[182569108]
A cardiomyopathy patient was admitted for a workup for a possible left ventricular assist device (lvad) and ablation to treat underlying ventricular tachycardia (vt). He had an impella 5. 0 placed via the right axillary artery, despite the observation made of a thrombus in the left ventricle, which is listed as a contraindication in the ifu for the impella 5. 0. The patient had his vt ablation procedure while on the support of the 5. 0. Post ablation he was sent to the icu for continued monitoring. While in the icu he exhibited signs of hemolysis. The team decided to explant the 5. 0 and not replace the pump. The patient had been supported by the impella for approximately 2 days.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2020-00344 |
| MDR Report Key | 9726538 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2020-02-19 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-01-24 |
| Date Facility Aware | 2020-01-24 |
| Date Mfgr Received | 2020-01-24 |
| Device Manufacturer Date | 2019-08-19 |
| Date Added to Maude | 2020-02-19 |
| 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 EUROPE GMBH |
| Manufacturer Street | NEUENHOFER WEG 3 |
| Manufacturer City | AACHEN 52074 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 52074 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPELLA 5.0 |
| Generic Name | TEMPORARY NONROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP |
| Product Code | OZD |
| Date Received | 2020-02-19 |
| Model Number | IMPELLA 5.0 AIC PUMP SET US |
| Catalog Number | 05062 |
| Lot Number | 1429219 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-02-19 |