IMPELLA
Report
- Report Number
- 1220648-2026-07086
- Event Type
- Injury
- Date Received
- April 23, 2026
- Date of Event
- April 20, 2026
- Report Date
- April 23, 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
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
B5: ADDED UPDATED CLINICAL REVIEW. H6: ADDED CODE A01.
B1: ADDED ADVERSE EVENT. B5: ADDED CLINICAL REVIEW. D4: CORRECTED CATALOG NUMBER, SERIAL NUMBER, UDI. D6B: ADDED EXPLANT DATE. H1: CHANGED TO SERIOUS INJURY. H6: ADDED E050304.
H6: ADDED A01.
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.
AN IMPELLA 5.5 DEVICE WAS INSERTED VIA THE RIGHT AXILLARY SURGICAL ARTERIAL APPROACH IN A 56-YEAR-OLD FEMALE PATIENT FOR THE INDICATION OF CARDIOMYOPATHY. THE PATIENT¿S COMORBIDITIES WERE NOT REPORTED. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS IDENTIFIED AS SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) STAGE D CARDIOGENIC SHOCK. DURING IMPELLA 5.5 SUPPORT, PURGE SYSTEM BLOCKED ALARMS WERE REPORTED, ASSOCIATED WITH ELEVATED PURGE PRESSURE AND REDUCED PURGE FLOW. TROUBLESHOOTING WAS PERFORMED, INCLUDING STANDARD ASSESSMENT OF THE PURGE SYSTEM WITH NO RESOLUTION OF THE ALARMS. REPLACEMENT OF THE PURGE CASSETTE WAS ATTEMPTED; HOWEVER, THE CONDITION PERSISTED. A TISSUE PLASMINOGEN ACTIVATOR (TPA) PROTOCOL WAS INITIATED TO ADDRESS SUSPECTED BIOMATERIAL WITHIN THE PURGE SYSTEM. THE PURGE PRESSURE SUBSEQUENTLY DECREASED AND PURGE FLOW IMPROVED, RETURNING TO BASELINE WITHIN A FEW HOURS. NO FURTHER ISSUES WERE REPORTED FOLLOWING INTERVENTION. THE TPA WAS UTILIZED FOR THE HPP TO MITIGATE IMPACT OF BIOMATERIAL WITHIN THE MOTOR AND THERE WAS NO IMPACT ON THE PATIENT. THE REPORTED PURGE SYSTEM BLOCKAGE AND ASSOCIATED HIGH PURGE PRESSURE ARE CONSISTENT WITH KNOWN POTENTIAL DEVICE-RELATED AND PATIENT-RELATED FACTORS, INCLUDING BIOMATERIAL ACCUMULATION WITHIN THE PURGE SYSTEM DURING MECHANICAL CIRCULATORY SUPPORT. THE POST-PROCEDURE OUTCOME IS UNKNOWN.
AN IMPELLA 5.5 DEVICE WAS INSERTED VIA THE RIGHT AXILLARY SURGICAL ARTERIAL APPROACH IN A 56-YEAR-OLD FEMALE PATIENT FOR THE INDICATION OF CARDIOMYOPATHY. THE PATIENT¿S COMORBIDITIES WERE NOT REPORTED. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS IDENTIFIED AS SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) STAGE D CARDIOGENIC SHOCK. DURING IMPELLA 5.5 SUPPORT, PURGE SYSTEM BLOCKED ALARMS WERE REPORTED, ASSOCIATED WITH ELEVATED PURGE PRESSURE AND REDUCED PURGE FLOW. TROUBLESHOOTING WAS PERFORMED, INCLUDING STANDARD ASSESSMENT OF THE PURGE SYSTEM WITH NO RESOLUTION OF THE ALARMS. REPLACEMENT OF THE PURGE CASSETTE WAS ATTEMPTED; HOWEVER, THE CONDITION PERSISTED. A TISSUE PLASMINOGEN ACTIVATOR (TPA) PROTOCOL WAS INITIATED TO ADDRESS SUSPECTED BIOMATERIAL WITHIN THE PURGE SYSTEM. THE PURGE PRESSURE SUBSEQUENTLY DECREASED AND PURGE FLOW IMPROVED, RETURNING TO BASELINE WITHIN A FEW HOURS. NO FURTHER ISSUES WERE REPORTED FOLLOWING INTERVENTION. THE TPA WAS UTILIZED FOR THE HPP TO MITIGATE IMPACT OF BIOMATERIAL WITHIN THE MOTOR AND THERE WAS NO IMPACT ON THE PATIENT. THE REPORTED PURGE SYSTEM BLOCKAGE AND ASSOCIATED HIGH PURGE PRESSURE ARE CONSISTENT WITH KNOWN POTENTIAL DEVICE-RELATED AND PATIENT-RELATED FACTORS, INCLUDING BIOMATERIAL ACCUMULATION WITHIN THE PURGE SYSTEM DURING MECHANICAL CIRCULATORY SUPPORT. THE POST-PROCEDURE OUTCOME IS UNKNOWN.
THE COMPLAINANT REPORTED HIGH PURGE PRESSURE (HPP) / PURGE SYSTEM BLOCKED WITH THEIR IMPELLA 5.5 TISSUE PLASMINOGEN ACTIVATOR WAS UTILIZED FOR THE HPP TO MITIGATE IMPACT OF BIOMATERIAL WITHIN THE MOTOR AND THERE WAS NO IMPACT ON THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 82808 | IMPELLA | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP | OZD | ABIOMED, INC. - 1220648 | 2027836092 | 00813502012828 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |