IMPELLA CP
Report
- Report Number
- 1220648-2026-00043
- Event Type
- Injury
- Date Received
- January 4, 2026
- Date of Event
- November 21, 2022
- Report Date
- January 3, 2026
- Manufacturer
- ABIOMED, INC.
- Product Code
- OZD
- UDI-DI
- 04260113630280
- PMA / PMN Number
- P140003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE IMPELLA DEVICE HAS NOT BEEN RECEIVED FROM THE CUSTOMER. THEREFORE, INVESTIGATION OF THE DEVICE IS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.
CORRECTED INFORMATION HAS BEEN PROVIDED IN B5 (EVENT DESCRIPTION). 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.
B2. REVISED SELECTION AS INTERVENTION WAS NOTED. B5. INFORMATION WAS ADDED THAT WAS OMITTED FROM THE INITIAL REPORT THAT WAS SUBMITTED. D4. ADDED EXPIRATION DATE AS IT WAS OMITTED FROM THE INITIAL REPORT THAT WAS SUBMITTED. D6A. AND D6B. IMPLANT AND EXPLANT DATES WERE ADDED AS THEY WERE OMITTED FROM THE INITIAL REPORT THAT WAS SUBMITTED. E1. ADDED INITIAL REPORTER FACILITY NAME AND ADDRESS AS IT WAS OMITTED FROM THE INITIAL REPORT THAT WAS SUBMITTED. E4. ADDED SELECTION AS IT WAS OMITTED FROM THE INITIAL REPORT THAT WAS SUBMITTED. G1. ADDED MANUFACTURING SITE NAME AND ADDRESS AS IT WAS OMITTED FROM THE INITIAL REPORT THAT WAS SUBMITTED. H6. HEALTH EFFECT - CLINICAL CODE FOR INFLAMMATION WAS ADDED DUE INFORMATION RECEIVED THAT WAS ADDED TO B5. HEALTH EFFECT-IMPACT CODE WAS UPDATED DUE INFORMATION RECEIVED THAT WAS ADDED TO B5.
H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. INVESTIGATION SUMMARY: NO PRODUCT RETURN. ACCESS SITE ADVERSE EVENT/HEMATOMA/MINOR BLEED: THE CAUSE OF THE ACCESS SITE ADVERSE EVENT WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. INFLAMMATION/PAIN: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY REVIEW: THE PUMP PASSED ALL THE POST STERILE INSPECTION CHECKS.
PROTECT IC FORWARDED TO THE COMPLAINTS TEAM AN ADVERSE EVENT. IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ACCESS-SITE¿RELATED SUBCUTANEOUS HEMATOMA. THE EVENT WAS CLASSIFIED AS MODERATE. MANUAL COMPRESSIONS WERE ADMINISTERED. NO ADDITIONAL INFORMATION WAS PROVIDED.
AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY ACCESS TO SUPPORT A PATIENT OF UNKNOWN/UNDOCUMENTED AGE AND GENDER WHO HAD BEEN ADMITTED IN WITH KNOWN CORONARY ARTERY DISEASE WITH INDICATION OF A PLANNED PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PCI). THE UNDERLYING MEDICAL HISTORY WAS NOT SHARED. THE CP SUPPORTED THE PATIENT SUCCESSFULLY FOR THE PCI AND WAS EXPLANTED AFTER THE PCI PROCEDURE. THREE DAYS POST HOSPITAL DISCHARGE THE PATIENT RETURNED WITH PAIN, SWELLING, AND A HEMATOMA AT THE GROIN SITE. IMAGING WAS PERFORMED TO EVALUATE THE HEMATOMA AND MEDICAL MANAGEMENT WAS PERFORMED FOR THE DIAGNOSED ANEURYSM SPURIUM. THE MEDICAL MANAGEMENT WAS INCLUSIVE OF ANTIMICROBIAL SOLUTION AND AN ADHESIVE PLASTER. THE PSEUDOANEURYSM DID REQUIRE MANUAL COMPRESSION AND THE PATIENT SURVIVED THE HARM. ANTICOAGULATION NECESSARY FOR THE PUMP PLACEMENT AND SUPPORT CAN CONTRIBUTE TO ACCESS SITE BLEEDING, HOWEVER THIS HEMATOMA WAS DISCOVERED 3 DAYS POST EXPLANT.
INFORMATION WAS RECEIVED THAT A SUBCUTANEOUS HEMATOMA OCCURRED IN THE LEFT GROIN. THERE WERE CONSERVATIVE WITH THE PROCEDURE AND THE PATIENT WAS DISCHARGED. THREE DAYS LATER, THE PATIENT WAS HOSPITALIZED BECAUSE OF BLEEDING, SWELLING AND PAIN IN THE LEFT GROIN. HEMOGLOBIN WAS 7.2 MMOL/L. MANUAL COMPRESSION WAS DONE FOR OVER 20 MINUTES. 3.75 MILLIGRAMS OF DIPIDOLOR WAS GIVEN INTRAVENOUSLY. AN ANEURYSM SPURIUM WAS DIAGNOSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2329 | IMPELLA CP | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP | OZD | ABIOMED, INC. | IMPELLA CP | 2023250761 | 04260113630280 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| O |