IMPELLA 5.5
Report
- Report Number
- 1220648-2026-00239
- Event Type
- Injury
- Date Received
- January 7, 2026
- Date of Event
- December 31, 2025
- Report Date
- March 20, 2026
- Manufacturer
- ABIOMED, INC.
- Product Code
- OZD
- UDI-DI
- 00813502013276
- PMA / PMN Number
- P140003
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE INVESTIGATION IS STILL ONGOING.
B3, D4 (SERIAL, CATALOG & PRIMARY UDI NUMBER) HAS BEEN UPDATED. 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.
HEMATURIA: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. HIGH PURGE PRESSURE: THE CAUSE OF THE ISSUE WAS NOT ESTABLISHED AS NO PRODUCT WAS RETURNED FOR ANALYSIS, INSUFFICIENT DATA LOGS WERE RETURNED AND LIMITED CLINICAL INFORMATION WAS PROVIDED PLACEMENT SIGNAL ISSUE: THE CAUSE OF THE ISSUE WAS NOT ESTABLISHED AS NO PRODUCT WAS RETURNED FOR ANALYSIS, INSUFFICIENT DATA LOGS WERE RETURNED AND LIMITED CLINICAL INFORMATION WAS PROVIDED.
A 61-YEAR-OLD MALE PATIENT WITH ACUTE ON CHRONIC DECOMPENSATED HEART FAILURE (CARDIOMYOPATHY) CARDIOGENIC SHOCK UNDER CARDIOPULMONARY RESUSCITATION WITH A MEAN ATRIAL PRESSURE OF 82 MMHG (UNDER 2 CATECHOLAMINES) AND AN ARTERIAL LACTATE OF 1.2 MMOL/L IN SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS SHOCK STAGE D. IMPELLA 5.5 WAS INSERTED WITHOUT COMPLICATIONS. AFTER 14 DAYS OF SUPPORT THE FIRST COMPLAINT WAS FILED AS THE AUTOMATED IMPELLA CONTROLLER DISPLAYED THE WHITE ¿UNEXPECTED CONSOLE SHUTDOWN¿ ALARM TWICE. HOWEVER, THE CONSOLE CONTINUED TO RUN WITHOUT ANY HARM TO THE PATIENT. NEVERTHELESS, THE IMPELLA 5.5 WAS CHANGED FOR A NEW IMPELLA 5.5 PUMP. THE SECOND COMPLAINT WAS REPORTED AFTER 8 DAYS OF DURATION OF THE SECOND IMPELLA 5.5 PUMP, AS THE TREATING PHYSICIAN OBSERVED THAT THE PURGE FLOW HAD FALLEN BELOW 2 MILLILITERS PER HOUR AND THAT A HIGH PUMP PRESSURE ALARM HAD OCCURRED. THE PURGE SYSTEM WAS REVIEWED IN DETAIL, AND MONITORING OF THE MOTOR CURRENT WAS RECOMMENDED. THE PURGE FLOW HAD DECREASED TO 2.5 MILLILITERS PER HOUR WITHOUT TRIGGERING ALARMS AND THE CARING NURSE CONFIRMED THAT THE PUMP WAS FUNCTIONING NORMALLY. THE REDUCED PURGE FLOW WAS ADDRESSED, AND THE CASE WAS FORWARDED TO THE RESPONSIBLE PHYSICIAN. RECOMMENDATIONS AND BEST CLINICAL PRACTICES WERE PROVIDED. THE PHYSICIAN REQUESTED LOCAL THROMBOLYSIS WITH TISSUE PLASMINOGEN ACTIVATOR. THE DAY AFTER THE PHYSICIAN REPORTED SUCCESSFUL THROMBOLYSIS BUT EXPRESSED CONCERN ABOUT THE CONTINUED TREND OF DECREASING PURGE FLOW, WHICH HAD AGAIN FALLEN TO 3.5 MILLILITERS PER HOUR. FURTHER RECOMMENDATIONS AND BEST CLINICAL PRACTICES WERE PROVIDED. ON DAY 13 OF THE DURATION OF THE SECOND IMPELLA 5.5, THE PHYSICIAN REPORTED A RENEWED DECLINE IN PURGE FLOW OVER RECENT DAYS, INCLUDING A DROP BELOW 3 MILLILITERS PER HOUR DURING THE PREVIOUS NIGHT. THE TEAM PLANNED TO REPEAT THROMBOLYSIS AS PER BEST PRACTICES. AGAIN, 10 DAYS LATER (DAY 23), THE PUMP WAS REPORTED TO BE FUNCTIONING WELL WITH A PUMP PRESSURE OF 642 MILLIMETERS OF MERCURY AND A PURGE FLOW OF 7.1 MILLILITERS PER HOUR. ON. THE SAME DAY THE THIRD COMPLAINT WAS FILED AS THE URINARY OUTPUT THOUGH GREATER THAN 30 CC/HOUR WAS PINK RED, WHICH COULD BE A SIGN FOR HEMATURIA. THE PATIENT WAS STILL ON SUPPORT WHEN THE DOCUMENTATION OF THE COMPLAINT CEASED ON THE (B)(6) 2026, SO POTENTIALLY OFF-LABEL USE OF LONGER THAN 29 DAYS ONCE REACHED THE (B)(6) WITHOUT ANOTHER PUMP EXCHANGE. A 69-YEAR-OLD MALE PATIENT WITH KNOWN DIABETES MELLITUS AND RENAL INSUFFICIENCY RECEIVED AN IMPELLA 5.5 VIA THE RIGHT AXILLARY/SUBCLAVIAN ARTERY. THE PATIENT HAD TO BE TAKEN BACK TO THE OPERATING ROOM TO EVALUATE THE ACCESS SITE FOR A HEMATOMA AND RETURNED WITH ADEQUATE HEMOSTASIS. A COMPLAINT WAS FILED FOR THIS EVENT. THE PATIENT SUBSEQUENTLY PRESENTED WITH RED-TINGED URINE IN THE FOLEY CATHETER, AND THE PHYSICIAN WAS UNABLE TO DETERMINE HEMOLYSIS VERSUS HEMATURIA. ANOTHER COMPLAINT WAS FILED. LATER, THE PATIENT DEVELOPED A BOWEL OBSTRUCTION, AND AN ADDITIONAL COMPLAINT WAS FILED. THE PATIENT WAS SUCCESSFULLY BRIDGED TO A LEFT VENTRICULAR ASSIST DEVICE AND SURVIVED.
THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER. THEREFORE, THE INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.
THE COMPLAINANT ALSO REPORTED THAT THE OPTICAL SENSOR WAS DEFECTIVE; RELIABLE PLACEMENT AND LEFT VENTRICLE SIGNALS WERE NO LONGER SHOWING ON THE ACCOMPANYING AUTOMATED IMPELLA CONTROLLER.
THE COMPLAINANT REPORT THAT A PATIENT WAS IMPLANTED WITH AN IMPELLA 5.5 FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THAT THE PURGE FLUID DROPPED BELOW TWO MILLILITERS PER HOUR (ML/H) AND "PP HIGH" ALARM OCCURRED. MOTOR CURRENT WAS TO BE MONITORED. THE PUMP RUNS WELL WITHOUT ANY PROBLEMS AND THE DECREASED PURGE FLUID WAS ADDRESSED. LOCAL ISSUE PLASMINOGEN ACTIVATOR (TPA) LYSIS WAS MENTIONED AND REQUESTED BY THE DOCTOR. FLUID WAS CHANGED TO 50 MILLILITERS OF AQUA ADDED AND TPA WAS PERFORMED TOGETHER. THE FOLLOWING DAY, THE MEDICAL DOCTOR REPORTED THAT THE LYSIS WAS SUCCESSFUL AND IS WANTING TO KNOW ABOUT PURGE FLUID AND PURGE PRESSURE TREND.. PURGE FLUID WAS SLIGHTLY DECREASED AGAIN TO 3.5 ML/H. FOUR DAYS LATER, THE MEDICAL DOCTOR REPORTED THAT PURGE FLUID TREND HAS AGAIN SHOWN A NEGATIVE DEVELOPMENT IN RECENT DAYS CAUSING THE PURGE FLUID TO DROP BELOW THREE ML/H DURING THE PAST NIGHT. THE DOCTOR WANTS TO APPLY TPA AGAIN. HEMATURIA WAS NOTED. URINARY OUTPUT WAS GREATER THAN 30 CUBIC CENTIMETERS PER HOUR AND WAS PINK-RED. THIS IS ONE OF TWO RELATED REPORTS. THIS REPORT REPRESENT THE IMPELLA 5.5 AND ANOTHER REPORT WAS SUBMITTED TO REPRESENT THE AUTOMATED IMPELLA CONTROLLER. REFER TO SECTION H10 FOR THE RELATED REPORT NUMBER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 303703 | IMPELLA 5.5 | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP | OZD | ABIOMED, INC. | IMPELLA 5.5 | 2026709622 | 00813502013276 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |