IMPELLA CP
Report
- Report Number
- 1220648-2025-48412
- Event Type
- Death
- Date Received
- November 18, 2025
- Date of Event
- October 20, 2025
- Report Date
- December 31, 2025
- Manufacturer
- ABIOMED, INC.
- Product Code
- OZD
- UDI-DI
- 00813502011876
- PMA / PMN Number
- P140003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
INVESTIGATION SUMMARY: CARDIAC ARREST : THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY LOT: DEVICE LOT : 1931409. DEVICE HISTORY BATCH: SUB-COMPONENT LOT : N/A. DEVICE HISTORY REVIEW: THE PUMP S/N: (B)(6) PASSED ALL THE POST STERILE INSPECTION CHECKS.
THE IMPELLA DEVICE IS NOT AVAILABLE FOR RETURN. THEREFORE, AN INVESTIGATION OF THE DEVICE IS NOT POSSIBLE. SHOULD ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.
THE USER FACILITY REPORTED A PATIENT WAS PLACED ON IMPELLA CP SUPPORT FOR A ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK. WHILE ON SUPPORT, THE PATIENT CONTINUED TO REMAIN SEVERELY ACIDOTIC AND HYPOTENSIVE DESPITE MEDICAL MANAGEMENT. THE PATIENT WENT INTO PULSELESS ELECTRICAL ACTIVITY ARREST WITH CARDIOPULMONARY RESUSCITATION FOR 15 MINUTES BEFORE THERE WAS A RETURN OF SPONTANEOUS CIRCULATION AGAIN. THE FAMILY DECIDED TO MAKE THE PATIENT DO NOT RESUSCITATE AND ULTIMATELY THE PATIENT PASSED SHORTLY AFTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2363555 | IMPELLA CP | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP | OZD | ABIOMED, INC. | IMPELLA CP | 2026675650 | 00813502011876 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Female | Death| R |