IMPELLA 5.5
Report
- Report Number
- 1220648-2025-25925
- Event Type
- Death
- Date Received
- January 30, 2025
- Date of Event
- January 14, 2025
- Report Date
- April 2, 2025
- Manufacturer
- ABIOMED, INC.
- Product Code
- OZD
- UDI-DI
- 00813502012828
- PMA / PMN Number
- P140003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE INVESTIGATION OF STROKE/CVA HAS BEEN COMPLETED. THE IMPELLA DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT ADDITIONAL CLINICAL DETAILS, THE ROOT CAUSE OF THE REPORTED ISSUES COULD NOT BE DETERMINED. E4 SHOULD HAVE BEEN LEFT BLANK ON MANUFACTURER DEVICE REPORT 1220648-2025-25925.
ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE PATIENTS OUTCOME. THE FAMILY DECIDED TO WITHDRAW CARE AND THE PATIENT EXPIRED. IT IS UNKNOWN IF THE USE OF THE IMPELLA WAS RELATED TO THE PATIENTS DEATH. THUS, THERE IS NOT ENOUGH EVIDENCE TO EXCLUDE IMPELLA AS AN ASSOCIATED FACTOR IN THE PATIENT'S OUTCOME. B.2 REVISED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-25925 TO REFLECT THE PATIENT OUTCOME OF DEATH AND DATE OF DEATH WAS ADDED. B.5 REVISED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-25925 TO ADD THE PATIENT OUTCOME OF DEATH. D.6B ADDED EXPLANT DATE AS IT WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-25925. E.1 ADDED FAX NUMBER AS IT WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-25925. H.1 TYPE OF REPORT WAS REVISED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-25925 TO REFLECT THE PATIENT OUTCOME OF DEATH. H.6 HEALTH EFFECT - IMPACT CODE WAS REVISED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-25925 TO REFLECT THE PATIENT OUTCOME OF DEATH. H.10 ADDED INFORMATION THAT WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-25925.
THE IMPELLA DEVICE HAS NOT BEEN RECEIVED FROM THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE HAS NOT BEEN POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED. INSTRUCTIONS FOR USE STATE THE FOLLOWING: IMPELLA CP WITH SMART ASSIST SYSTEM & IMPELLA 5.5 WITH SMART ASSIST FOR USE DURING CARDIOGENIC SHOCK SECTION: POTENTIAL ADVERSE EVENTS (UNITED STATES) ¿ACUTE RENAL DYSFUNCTION, AORTIC VALVE INJURY, BLEEDING, CARDIOGENIC SHOCK, CEREBRAL VASCULAR ACCIDENT/STROKE, DEATH, HEMOLYSIS, LIMB ISCHEMIA, MYOCARDIAL INFARCTION, RENAL FAILURE, THROMBOCYTOPENIA AND CARDIAC OR VASCULAR INJURY (INCLUDING VENTRICULAR PERFORATION).¿ SECTION: WARNINGS, CAUTIONS & PRECAUTIONS: ¿TO REDUCE THE POSSIBILITY OF FIBERS BEING DRAWN INTO THE IMPELLA, CUSTOMERS SHOULD AVOID EXPOSING THE INLET AND CANNULA SECTION OF THE IMPELLA HEART PUMPS TO ANY SURFACES OR FLUID BATHS WHERE THE DEVICE CAN COME INTO CONTACT WITH LOOSE OR FLOATING FIBERS.¿
ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE PATIENT'S OUTCOME. THE FAMILY DECIDED TO WITHDRAW CARE AND THE PATIENT EXPIRED. IT IS UNKNOWN IF THE USE OF THE IMPELLA WAS RELATED TO THE PATIENT'S DEATH. THUS, THERE IS NOT ENOUGH EVIDENCE TO EXCLUDE IMPELLA AS AN ASSOCIATED FACTOR IN THE PATIENT'S OUTCOME.
THE US COMPLAINANT HAD PLACED A 5.5 PUMP TO SUPPORT A PATIENT ADMITTED IN WITH MULTIPLE COMORBIDITIES WHILE AWAITING TRANSPLANT. DURING THE SUPPORT THERE WAS A CEREBROVASCULAR ACCIDENT. THE TEAM QUESTIONED CLOT INGESTION AS THE HEPARIN HAD BEEN STOPPED SYSTEMICALLY IN PREPARATION FOR THE TRANSPLANT. THE IMPELLA REMAINS ON FOR SUPPORT (WITH SODIUM BICARB IN PURGE) DESPITE THE HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 510794 | IMPELLA 5.5 | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP | OZD | ABIOMED, INC. | IMPELLA 5.5 | 2025567219 | 00813502012828 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Male | Death| R |