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 2020-02-21 for IMPELLA CP IMPELLA CP PUMP 371 SET, US 0048-0032 manufactured by Abiomed Inc..
[182002084]
The investigation into the low flows and limb ischemia are on-going at this time. Upon investigation completion, a final report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[182002085]
A (b)(6) old patient was admitted in cardiogenic shock. The team placed an impella cp for support via the right femoral artery. The team consulted cardiothoracic surgery for possible bypass. While in the icu, awaiting bypass surgery, the team observed the impella flow to drop. Troubleshooting was attempted. The team observed a thrombus present within the left ventricle (lv). The presence of clot within the lv is a noted concern within the ifu. The team chose to explant the impella. At removal the medical team also had to care for the patient as the right leg became ischemic. A thrombectomy was done.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2020-00348 |
| MDR Report Key | 9742061 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-21 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-01-27 |
| Date Facility Aware | 2020-01-27 |
| Date Mfgr Received | 2020-01-27 |
| Device Manufacturer Date | 2019-10-18 |
| Date Added to Maude | 2020-02-21 |
| 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 NONROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP |
| Product Code | OZD |
| Date Received | 2020-02-21 |
| Returned To Mfg | 2020-02-03 |
| Model Number | IMPELLA CP PUMP 371 SET, US |
| Catalog Number | 0048-0032 |
| Lot Number | 1439840 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2020-02-21 |