IMPELLA
Report
- Report Number
- 1220648-2026-06299
- Event Type
- Injury
- Date Received
- April 2, 2026
- Date of Event
- March 26, 2026
- Manufacturer
- ABIOMED, INC. - 1220648
- Product Code
- OZD
- UDI-DI
- 00813502012828
- PMA / PMN Number
- P140003
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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.
B5 CLINICAL NARRATIVE UPDATED.
D4 SERIAL AND PRIMARY UDI NUMBER WERE REVISED. D6B EXPLANT DATE WAS ADDED.
H6 CODES HAVE BEEN UPDATED.
CLINICAL NARRATIVE: AN IMPELLA 5.5 DEVICE WAS INSERTED SURGICALLY INTO THE RIGHT AXILLARY/SUBCLAVIAN ARTERY IN A 57-YEAR-OLD MALE PATIENT PRESENTING IN HEART FAILURE, CARDIOGENIC SHOCK, CARDIOMYOPATHY, IN SCAI STAGE D SHOCK, ON MULTIPLE INOTROPES AND VASOPRESSORS, PRIOR TO INITIATION OF SUPPORT. WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), THERE WAS HIGH PURGE PRESSURES IN THE UPPER 600'S AND FLOWS IN THE RANGE OF 3-5ML/HR. TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS INITIATED. THE PATIENT HAS BEEN THERAPEUTIC ON PARTIAL THROMBOPLASTIN TIME (PTT) ON SYSTEM HEPARIN. THERE WAS NO NOTED INTERRUPTION OF FLOW OR SUPPORT FOR THE PATIENT. THE POST-PROCEDURE OUTCOME IS UNKNOWN. THE IMPELLA FUNCTIONED AT P-7 AT 3.5LMIN AS INTENDED. HIGH PURGE PRESSURE IN AN IMPELLA DEVICE CAN BE CAUSED BY THROMBUS BUILDUP WITHIN THE MOTOR PURGE GAP, WHICH RESTRICTS THE FLOW OF THE PURGE SOLUTION. THIS IS OFTEN CHARACTERIZED BY A GRADUAL INCREASE IN PURGE PRESSURE, LOW PURGE FLOW, AND A POTENTIAL PURGE SYSTEM BLOCKED ALARM. THIS CAN BE CORRECTED BY USING TPA.
UPDATED CLINICAL NARRATIVE: AN IMPELLA 5.5 DEVICE WAS INSERTED SURGICALLY INTO THE RIGHT AXILLARY/SUBCLAVIAN ARTERY IN A 57-YEAR-OLD MALE PATIENT PRESENTING IN HEART FAILURE, CARDIOGENIC SHOCK, CARDIOMYOPATHY, IN SCAI STAGE D SHOCK, ON MULTIPLE INOTROPES AND VASOPRESSORS, PRIOR TO INITIATION OF SUPPORT. WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), THERE WAS HIGH PURGE PRESSURES IN THE UPPER 600'S AND FLOWS IN THE RANGE OF 3-5ML/HR. TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS INITIATED. THE PATIENT HAS BEEN THERAPEUTIC ON PARTIAL THROMBOPLASTIN TIME (PTT) ON SYSTEM HEPARIN. THERE WAS NO NOTED INTERRUPTION OF FLOW OR SUPPORT FOR THE PATIENT. IN ADDITION, THERE WAS A LOSS OF PLACEMENT SIGNAL AFTER THE IMPELLA WAS REPOSITIONED WITH AN ECHOCARDIOGRAM. NO AORTIC (AO) OR LEFT VENTRICLE (LV) SIGNAL WAS NOTED. THE NURSE SILENCED THE PLACEMENT ALARMS. THE POST-PROCEDURE OUTCOME IS UNKNOWN. THE IMPELLA FUNCTIONED AT P-7 AT 3.5 LMIN AS INTENDED. HIGH PURGE PRESSURE IN AN IMPELLA DEVICE CAN BE CAUSED BY THROMBUS BUILDUP WITHIN THE MOTOR PURGE GAP, WHICH RESTRICTS THE FLOW OF THE PURGE SOLUTION. THIS IS OFTEN CHARACTERIZED BY A GRADUAL INCREASE IN PURGE PRESSURE, LOW PURGE FLOW, AND A POTENTIAL PURGE SYSTEM BLOCKED ALARM. THIS CAN BE CORRECTED BY USING TPA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 227718 | IMPELLA | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP | OZD | ABIOMED, INC. - 1220648 | 2026804416 | 00813502012828 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |