BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24468666 · Received February 27, 2026

    Report

    Report Number
    1220648-2026-04185
    Event Type
    Death
    Date Received
    February 27, 2026
    Date of Event
    February 17, 2026
    Report Date
    March 13, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    B1/B2, B5, AND H6 UPDATED. THE INVESTIGATION IS STILL ONGOING.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION HAS BEEN PROVIDED IN D1 BRAND NAME. H6 INVESTIGATION: TYPE, FINDINGS, AND CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE CAUSE OF THE ISSUE WAS NOT ESTABLISHED AS NO PRODUCT OR LOGS WERE RETURNED AND INSUFFICIENT INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    AN IMPELLA 5.5 WAS PLACED VIA SURGICAL RIGHT AXILLARY/SUBCLAVIAN ARTERIAL ACCESS IN A 74 YEAR OLD MALE FOR AMI/CGS. THE PATIENT¿S COMORBIDITIES ARE KNOWN CAD, DIABETES MELLITUS, AND RENAL INSUFFICIENCY. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS DOCUMENTED AS SCAI SHOCK STAGE E. INITIALLY, TWO DAYS PRIOR, AN IMPELLA CP WAS IMPLANTED AND THEN EXPLANTED THE SAME DAY FOLLOWING PUMP STOP AND PURGE PRESSURE HIGH ALARMS; ATTEMPTS TO RESTART THE PUMP WERE UNSUCCESSFUL AND A NEW CP WAS PLACED (B)(4). THE SECOND IMPELLA CP WAS SUBSEQUENTLY BRIDGED FOR MORE DURABLE SUPPORT TO THE IMPELLA 5.5 AND AN IMPELLA RP FLEX. THE FOLLOWING DAY, THE IMPELLA RP FLEX DEVICE WAS REMOVED AFTER LOW PUMP FLOW IN THE SETTING OF SUSPECTED CLOT INGESTION DURING TRANSPORT (PC-002091250). THE NEXT DAY, DURING IMPELLA 5.5 SUPPORT, THE PATIENT¿S PLASMA FREE HEMOGLOBIN LEVEL WAS 300 MG/DL AND LDH 1200 U/L CONSISTENT WITH HEMOLYSIS. IMAGING CONFIRMED APPROPRIATE PUMP POSITION, AND THERE WAS NO CONTACT WITH THE MITRAL APPARATUS. NO ANATOMIC CARDIAC ABNORMALITIES WERE REPORTED. IT IS UNKNOWN WHETHER THERE WAS ORGAN DAMAGE. THE PATIENT REMAINS ON IMPELLA 5.5 SUPPORT AT THE TIME OF REPORTING AND SURVIVAL OUTCOME AT EXPLANT IS TO BE DETERMINED. HEMOLYSIS IS A KNOWN RISK ASSOCIATED WITH IMPELLA 5.5 AS DESCRIBED IN THE INSTRUCTIONS FOR USE (IFU).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION HAS BEEN PROVIDED UPON REQUEST: "CARE WAS WITHDRAWN ON THIS PATIENT AND PUMP WAS NOT EXPLANTED. DEVICE IS NOT AVAILABLE FOR RETURN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533435 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 IMPELLA 5.5 WITH SMARTASSIST S2 SET, US 2026774679 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention| D