IMPELLA
Report
- Report Number
- 1220648-2026-07846
- Event Type
- Death
- Date Received
- May 14, 2026
- Date of Event
- May 11, 2026
- Report Date
- May 19, 2026
- Manufacturer
- ABIOMED, INC. - 1220648
- Product Code
- OZD
- UDI-DI
- 00813502012828
- PMA / PMN Number
- P140003
- Removal / Correction Number
- 95129
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- 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.
B1/B2 AND H1 UPDATED TO REFLECT PATIENT DEATH. B5 UPDATED WITH UPDATED CLINICAL NARRATIVE. D6B UPDATED. REMOVED F26 FROM H6; F02 AND F2303 ADDED TO H6. THE INVESTIGATION IS STILL ONGOING.
COMPLAINT CODING WAS UPDATED TO BETTER REFLECT THE REPORTED EVENT. CONSEQUENTLY, SECTION H6 MEDICAL DEVICE PROBLEM CODE A140508 WAS REMOVED.
CORRECTED DATA THIS REPORT IS BEING SUBMITTED TO CORRECT H9. UPON FURTHER REVIEW, IT WAS DETERMINED THAT THE REPORT WAS INCORRECTLY ASSOCIATED WITH A RECALL. THIS INFORMATION WAS ENTERED IN ERROR, AND WITH CURRENT INFORMATION THE EVENT IS NOT ASSOCIATED WITH ANY RECALL. THE INVESTIGATION IS STILL ONGOING.
THE COMPLAINANT REPORTED THEIR IMPELLA 5.5'S PURGE SYSTEM WAS WORKING AS NORMAL, READING FLOW OF 11 AND PRESSURE OF 550. THE NURSE FOLLOWED THE ¿DE AIR¿ PROTOCOL TO REMOVE UNNECESSARY EXTENSION TUBING. ABOUT 60 MINUTES LATER THE SYSTEM BEGAN ALARMING PURGE PRESSURE HIGH. THE PURGE LINE WAS ASSESSED FOR KINKS AND NONE WERE FOUND. DEXTEOSE CONCENTRATION WAS UNABLE TO BE REDUCED. THE COMPLAINANT CALLED AGAIN ON THE SAME DAY, REPORTING THE SYSTEM WAS READING PURGE SYSTEM BLOCKED. THE COMPLAINANT WAS REFERRED TO THE CUSTOMER SERVICE CENTER FOR FURTHER ASSISTANCE AND TISSUE PLASMINOGEN ACTIVATOR PROTOCOL. NO PATIENT HARM HAS BEEN REPORTED.
AN IMPELLA 5.5 DEVICE WAS INSERTED SURGICALLY INTO THE RIGHT AXILLARY/SUBCLAVIAN ARTERY IN A 66-YEAR-OLD MALE PATIENT PRESENTING IN ACUTE DECOMPENSATED CARDIOMYOPATHY, IN SCAI STAGE E SHOCK, AND ON MULTIPLE INOTROPES AND VASOPRESSORS, PRIOR TO INITIATION OF SUPPORT. WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), THE NURSE PERFORMED ROUTINE DE-AIR PROTOCOL TO REMOVE UNNECESSARY EXTENSION TUBING. ABOUT 60 MINUTES LATER, THE SYSTEM BEGAN ALARMING PURGE PRESSURE HIGH, WHICH PROGRESSED TO PURGE SYSTEM BLOCKED. NO KINKS WERE NOTED. CHANGING THE PURGE CASSETTE DID NOT RESOLVE THE ISSUE. TISSUE PLASMINOGEN ACTIVATOR (TPA) PROTOCOL WAS INITIATED. AFTER 13 DAYS ON SUPPORT, THE PATIENT EXPIRED. WHILE ON SUPPORT, THE DEVICE FUNCTIONED AS INTENDED AT P-7 AT 3.7L/MIN WITH D5W SODIUM BICARBONATE IN THE PURGE SOLUTION. THE IMPELLA IS CONSERVATIVELY BEING REPORTED FOR DEATH; HOWEVER, IS UNLIKELY TO HAVE CONTRIBUTED TO THE PATIENT'S DEATH, WHICH WAS MOST LIKELY DUE TO THE CLINICAL CONDITION OF A CRITICALLY ILL PATIENT, DEPENDENT ON VASOPRESSOR SUPPORT, WITH DECOMPENSATED CARDIOMYOPATHY, COMPLICATED BY STAGE E SHOCK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 12205 | IMPELLA | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP | OZD | ABIOMED, INC. - 1220648 | 2026803204 | 00813502012828 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |