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 2020-03-17 for IMPELLA CP IMPELLA CP PUMP 0048-0024 manufactured by Abiomed Inc..
[183928100]
The complainant has returned the impella pump product for analysis. The analysis of the product and clinical details in on-going at this time. Upon the completion of the investigation, a final report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[183928101]
A patient was transferred in to the tertiary medical center for cardiology care. The patient was suffering from an acute myocardial infarction. She had decreased ejection fraction and coronary artery disease in need of intervention/angioplasty. For hemodynamic support an impella cp was placed via the left femoral artery. An external bypass was also placed due to diminished pulses in the lower limbs. She was anticoagulated with aspirin, heparin, aggrastat, and brilanta and supported with the impella for approximately 1 day when there was an observation made of a hematoma at the impella access site. The groin injury and associated bleeding prompted a vascular surgery repair and 2 units of blood product replacement. The patient remained on the impella support with the impella cp for 5 days.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2020-00378 |
| MDR Report Key | 9845467 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-02-23 |
| Date Facility Aware | 2020-02-23 |
| Date Mfgr Received | 2020-02-23 |
| Device Manufacturer Date | 2019-12-26 |
| Date Added to Maude | 2020-03-17 |
| 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 CP |
| Generic Name | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUM |
| Product Code | OZD |
| Date Received | 2020-03-17 |
| Returned To Mfg | 2020-03-04 |
| Model Number | IMPELLA CP PUMP |
| Catalog Number | 0048-0024 |
| Lot Number | 1453045 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-17 |