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 2020-03-01 for IMPELLA CP IMPELLA CP PUMP 371 SET, US 0048-0024 manufactured by Abiomed Inc..
[183470471]
The investigation into the separation of the impella cp, which allowed part of the pump to remain within the patient's lv, is on-going. Product has not been returned and more clinical details are expected. As more clinical details are shared, the cause of the reported aortic insufficiency and death will be analyzed. When the investigation concludes a final report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[183470472]
A patient admitted with coronary artery disease and mitral regurgitation was decompensating. Due to his cardiogenic shock he was taken to the cardiac catheterization lab for evaluation of his coronary arteries and was to have an impella cp placed for hemodynamic support. When the cp was placed in the left ventricle (lv), the pump placement was not optimal and so the physician attempted to adjust position. When adjusting the position the cp became kinked. As the physician was trying to remedy the kink and straighten the catheter the pump separated. To two pieces. A portion of the pump remained in the lv and a portion was across the valve. The patient condition began to decline and so the team chose to treat the underlying coronary artery, the left main. Cpr was administered and he portion of the impella not within the lv was removed and an intra-aortic balloon pump was placed. Despite these efforts the patient expired.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2020-00358 |
| MDR Report Key | 9772705 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-01 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-02-10 |
| Date Facility Aware | 2020-02-10 |
| Date Mfgr Received | 2020-02-10 |
| Device Manufacturer Date | 2020-01-07 |
| Date Added to Maude | 2020-03-01 |
| 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 | 2020-03-01 |
| Model Number | IMPELLA CP PUMP 371 SET, US |
| Catalog Number | 0048-0024 |
| Lot Number | 1454567 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-01 |