IMPELLA
Report
- Report Number
- 1220648-2026-04742
- Event Type
- Injury
- Date Received
- March 9, 2026
- Date of Event
- February 26, 2026
- Report Date
- April 29, 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
- AR, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
A4 PATIENT HEIGHT WAS ADDED. ADDITIONAL INFORMATION RECEIVED FOR D6 EXPLANT. SECTION D BRAND NAME CORRECTED.
A4 IS UNKNOWN. 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: ADDITIONAL EVENT INFORMATION RECEIVED.
B5 CLINICAL NARRATIVE UPDATED. SECTION D1 BRAND NAME CORRECTED. SECTION D4 CATALOG NUMBER WAS CORRECTED. H6: THE MEDICAL DEVICE CODE AND HEALTH EFFECT CLINICAL CODE WERE UPDATED.
THE INVESTIGATION FOR RENAL FAILURE AND HYPOTENSION HAS BEEN COMPLETED. THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. THE INVESTIGATION FOR HEMOLYSIS / MECHANICAL INTERACTION WITH BLOOD HAS BEEN COMPLETED. THE CAUSE OF THE HEMOLYSIS ISSUE COULD NOT BE DETERMINED WITHOUT THE RETURNED PRODUCT FOR INVESTIGATION AND SUFFICIENT CLINICAL DETAILS, INCLUDING DATA LOG. THE INVESTIGATION FOR LOW OR BLOCKED PUMP FLOW HAS BEEN COMPLETED. THE CAUSE OF THE LOW OR BLOCKED PUMP FLOW ISSUE COULD NOT BE DETERMINED WITHOUT THE RETURNED PRODUCT FOR INVESTIGATION AND SUFFICIENT CLINICAL DETAILS, INCLUDING DATA LOG. THE INVESTIGATION FOR PLACEMENT SIGNAL ISSUE HAS BEEN COMPLETED. THE CAUSE OF THE PLACEMENT SIGNAL ISSUE COULD NOT BE DETERMINED WITHOUT THE RETURNED PRODUCT FOR INVESTIGATION AND SUFFICIENT CLINICAL DETAILS, INCLUDING DATA LOG.
ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE IMPELLA DEVICE WAS EXPLANTED.
AN IMPELLA 5.5 DEVICE WAS INSERTED INTO THE RIGHT AXILLARY/SUBCLAVIAN ARTERY IN A 66-YEAR-OLD MALE PATIENT WITH A PAST MEDICAL HISTORY OF A PRIOR CORONARY ARTERY BYPASS GRAFT (CABG), AND CORONARY ARTERY DISEASE (CAD), PRESENTING IN ACUTE MYOCARDIAL INFARCTION (AMI) AND CARDIOGENIC SHOCK (CGS), IN AN OUT-OF-HOSPITAL CARDIAC ARREST REQUIRING CARDIOPULMONARY RESUSCITATION (CPR), IN SCAI STAGE D SHOCK, ON MULTIPLE INOTROPES AND VASOPRESSORS, AND ON A VENTILATOR FOR RESPIRATORY SUPPORT, PRIOR TO INITIATION OF SUPPORT. THE IMPELLA 5.5 WAS INSERTED AS AN ESCALATION OF THERAPY FROM AN IMPELLA CP. WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), THE PHYSICIAN WAS CONCERNED FOR HEMOLYSIS. THE LACTATE DEHYDROGENASE (LDH) WAS 800. THE PATIENT WAS ON CONTINUOUS RENAL REPLACEMENT (CRRT). THE FOLLOWING DAY, THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR A TRANSPLANT WORKUP. UPON ARRIVAL, THE STAFF ATTEMPTED TO PERFORM AN AUTOMATED IMPELLA CONTROLLER (AIC) TO AIC TRANSFER. THE PURGE DISC WAS NOT RECOGNIZABLE. THE FACILITY DECIDED TO KEEP THE AIC FROM THE OUTSIDE HOSPITAL. THE POST-PROCEDURE OUTCOME IS UNKNOWN. THE IMPELLA FUNCTIONED AT P-6 AT 4.5L/MIN AS INTENDED. HEMOLYSIS MAY BE INFLUENCED BY PATIENT-SPECIFIC FACTORS SUCH AS CRITICAL ILLNESS, UNDERLYING CARDIAC DYSFUNCTION, HEMODYNAMIC INSTABILITY, AND POTENTIAL DEVICE POSITION.
ADDITIONAL INFOMATION WAS RECEIVED REPORTING PATIENT TRANSFERRED TO VANDERBILT UNIVERSITY STILL ON SUPPORT.
UPDATED CLINICAL NARRATIVE: AN IMPELLA 5.5 DEVICE WAS INSERTED SURGICALLY INTO THE RIGHT AXILLARY/SUBCLAVIAN ARTERY IN A 66-YEAR-OLD MALE PATIENT WITH A PAST MEDICAL HISTORY OF A CORONARY ARTERY BYPASS GRAFT (CABG) AND CORONARY ARTERY DISEASE (CAD), PRESENTING IN ACUTE MYOCARDIAL INFARCTION (AMI) AND CARDIOGENIC SHOCK (CGS), IN AN OUT-OF-HOSPITAL CARDIAC ARREST REQUIRING CARDIOPULMONARY RESUSCITATION (CPR), IN SCAI STAGE D SHOCK, ON MULTIPLE INOTROPES AND VASOPRESSORS, AND ON A VENTILATOR FOR RESPIRATORY SUPPORT, PRIOR TO INITIATION OF SUPPORT. THE IMPELLA 5.5 WAS INSERTED AS AN ESCALATION OF THERAPY FROM AN IMPELLA CP. WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), THE PHYSICIAN WAS CONCERNED FOR HEMOLYSIS. THE LACTATE DEHYDROGENASE (LDH) WAS 800. THE PATIENT WAS ON CONTINUOUS RENAL REPLACEMENT (CRRT). THE FOLLOWING DAY, THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR A TRANSPLANT WORKUP. UPON ARRIVAL, THE STAFF ATTEMPTED TO PERFORM AN AUTOMATED IMPELLA CONTROLLER (AIC) TO AIC TRANSFER. THE PURGE DISC WAS NOT RECOGNIZABLE. THE FACILITY DECIDED TO KEEP THE AIC FROM THE OUTSIDE HOSPITAL. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ORTHOSTATIC HYPOTENSION. IMPELLA FLOWS DROPPED FROM P-4 AT 2.5L TO 1.5L/MIN. AN ECHOCARDIOGRAM SHOWED THE PUMP IN GOOD POSITION WITH LEFT VENTRICLE (LV) AND AORTIC (A) SIGNALS DECOUPLED. THERE WAS NO NOTED INTERRUPTION OF FLOW OR SUPPORT FOR THE PATIENT. THE TEAM DECIDED TO ADD VENOUS-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA ECMO). THE POST-PROCEDURE OUTCOME IS UNKNOWN. THE IMPELLA FUNCTIONED AT P-6 AT 4.5L/MIN AS INTENDED. HEMOLYSIS AND HYPOTENSION ARE KNOWN ADVERSE EVENTS AND MAY BE INFLUENCED BY PATIENT-SPECIFIC FACTORS SUCH AS CRITICAL ILLNESS, UNDERLYING CARDIAC DYSFUNCTION, HEMODYNAMIC INSTABILITY, AND POTENTIAL DEVICE POSITION. THE AUTOMATED IMPELLA CONTROLLER WILL BE CONSERVATIVELY REPORTED FOR HEMODYNAMIC INSTABILITY DUE TO TEMPORARY HEMODYNAMIC SUPPORT INTERRUPTION DURING THE EXCHANGE; HOWEVER, THE EXCHANGE WAS PERFORMED WITH NO CONSEQUENCE TO THE PATIENT AND SUPPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 301960 | IMPELLA | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP | OZD | ABIOMED, INC. - 1220648 | 2026798054 | 00813502012828 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |