IMPELLA
Report
- Report Number
- 1220648-2026-06419
- Event Type
- Injury
- Date Received
- April 6, 2026
- Date of Event
- March 27, 2026
- Manufacturer
- ABIOMED, INC. - 1220648
- Product Code
- OZD
- UDI-DI
- 00813502012279
- PMA / PMN Number
- P140003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ABIOMED INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ABIOMED INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
CLINICAL NARRATIVE: AN IMPELLA CP WAS INSERTED VIA THE 14FR INTRODUCER AT THE FEMORAL ARTERY TO SUPPORT THE (B)(6) MALE PATIENT WHO HAD BEEN ADMITTED IN WITH KNOWN CORONARY ARTERY DISEASE AND A PLAN FOR A PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PCI). THE MEDICAL HISTORY WAS NOT SHARED. THE MEDICAL TEAM OBSERVED AN ACCESS SITE HEMATOMA. THE HEMATOMA/BLEEDING WAS REMEDIED QUICKLY AND HEMOSTASIS ACHIEVED WITH THE USE OF 2 PERCLOSE. AT THE CONCLUSION OF THE PCI THE PUMP WAS EXPLANTED. THE PATIENT SURVIVED THE HEMATOMA. ANTICOAGULATION NECESSARY FOR THE PUMP PLACEMENT AND SUPPORT CAN CONTRIBUTE TO ACCESS SITE BLEEDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 233034 | IMPELLA | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP | OZD | ABIOMED, INC. - 1220648 | 2026792069 | 00813502012279 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |