IMPELLA CP
Report
- Report Number
- 1220648-2025-49276
- Event Type
- Injury
- Date Received
- December 24, 2025
- Date of Event
- September 22, 2025
- Manufacturer
- ABIOMED, INC.
- Product Code
- OZD
- UDI-DI
- 00813502011876
- PMA / PMN Number
- P140003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
INVESTIGATION SUMMARY: NO PRODUCT WAS RETURNED FOR INVESTIGATION. VENTRICULAR FIBRILLATION/ CARDIAC ARREST: IN ORDER TO MAKE A ROOT CAUSE DETERMINATION, ALL OF THE CLINICAL DETAILS OUTLINED IN ES2023-0158 WOULD HAVE TO BE PROVIDED. THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY LOT: DEVICE LOT: 1934164. DEVICE HISTORY BATCH: SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW: DEVICE WITH SN: (B)(6) PASSED ALL POST STERILE INSPECTION CHECKS.
THE COMPLAINANT REPORTED THAT AN IMPELLA CP PUMP WAS IMPLANTED TO SUPPORT A PATIENT UNDERGOING HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION. THE IMPELLA CP WAS SUCCESSFULLY POSITIONED ACROSS THE AORTIC VALVE, THE WIRE WAS REMOVED, AND MECHANICAL SUPPORT WAS INITIATED. THE PATIENT WAS DEFIBRILLATED ONCE AND RETURN OF SPONTANEOUS CIRCULATION WAS ACHIEVED. THE IMPELLA CP WAS RUN AT P-9 FOR THE DURATION OF THE PROCEDURE TO MAINTAIN HEMODYNAMIC STABILITY. IMPELLA SUPPORT WAS WEANED AFTER COMPLETION OF INTERVENTIONS, AND THE DEVICE WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2476019 | IMPELLA CP | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP | OZD | ABIOMED, INC. | IMPELLA CP | 2026688177 | 00813502011876 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Male | Required Intervention| H |