BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA 5.5 WITH SMARTASSIST S2 SET, US

    MDR report key: 24396725 · Received February 19, 2026

    Report

    Report Number
    1220648-2026-03614
    Event Type
    Death
    Date Received
    February 19, 2026
    Date of Event
    October 28, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER; THEREFORE, AN INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED. RELATED MEDICAL DEVICE REPORTS: THIS IS ONE OF TWO DEVICES ASSOCIATED WITH THE EVENT. REFER TO THE RELATED MANUFACTURER REPORT NUMBER(S) AS NOTED IN SECTION H10.

    Additional Manufacturer Narrative · 0

    H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. INVESTIGATION SUMMARY: PPAE (RENAL FAILURE): THE ROOT CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    AN 80-YEAR-OLD MALE WITH A PAST MEDICAL HISTORY SIGNIFICANT FOR FORMER TOBACCO USE, HYPERLIPIDEMIA (HLD), HYPERTENSION (HTN), PROSTATE CANCER (CA), AND BLADDER CANCER (CA) PRESENTED TO THE EMERGENCY DEPARTMENT (ED) WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI). CORONARY ANGIOGRAPHY DEMONSTRATED SIGNIFICANT DISEASE OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY REQUIRING PLACEMENT OF FOUR STENTS. AN IMPELLA CP WAS IMPLANTED FOR BAILOUT MECHANICAL CIRCULATORY SUPPORT DURING THE PROCEDURE. SUBSEQUENTLY, THE PATIENT DEVELOPED HEMOLYSIS, EVIDENCED BY CLINICAL AND LABORATORY FINDINGS CONSISTENT WITH RED BLOOD CELL DESTRUCTION. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY WITH WORSENING CARDIOGENIC SHOCK. DUE TO HEMODYNAMIC DETERIORATION, THE DECISION WAS MADE TO ESCALATE SUPPORT TO AN IMPELLA 5.5. THE IMPELLA 5.5 WAS SUCCESSFULLY INSERTED VIA THE RIGHT AXILLARY ARTERY USING A DOUBLE-BARREL TECHNIQUE. THE IMPELLA CP WAS REMOVED, AND HEMOSTASIS WAS ACHIEVED. DEVICE POSITION OF THE IMPELLA 5.5 WAS CONFIRMED BY TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE), MEASURED AT 4.0 CM, AND SECURED AT 42.5 CM WITH A THREE-POINT FIXATION DEVICE. THE DEVICE WAS MAINTAINED AT PERFORMANCE LEVEL P-6, AND THE PATIENT WAS TRANSFERRED TO THE CARDIOVASCULAR INTENSIVE CARE UNIT (CVICU) ON SUPPORT. DOCUMENTATION INDICATED PLANS TO INITIATE CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) DUE TO RENAL DYSFUNCTION; HOWEVER, IT IS UNKNOWN WHETHER CRRT WAS INITIATED. ON THE FOLLOWING DAY, THE PATIENT EXPIRED AFTER CARE WAS WITHDRAWN. HEMOLYSIS IS CONSIDERED A SERIOUS INJURY AND IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH IMPELLA CP SUPPORT; THEREFORE, THE HEMOLYSIS EVENT IS ATTRIBUTED TO THE IMPELLA CP. THE DEATH IS BEING ASSOCIATED WITH THE IMPELLA 5.5 BECAUSE THIS DEVICE WAS IN PLACE AT THE TIME OF DEATH. RENAL FAILURE IS ALSO BEING REPORTED IN ASSOCIATION WITH THE IMPELLA 5.5 DUE TO DOCUMENTED PLANS FOR CONTINUOUS RENAL REPLACEMENT THERAPY, ALTHOUGH INITIATION OF THERAPY COULD NOT BE CONFIRMED. THE LIKELY CAUSE OF DEATH IS THE PATIENT'S UNDERLYING CONDITION (SEVERE CORONARY ARTERY DISEASE AND CARDIOGENIC SHOCK [SCAI STAGE D]).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614425 IMPELLA 5.5 WITH SMARTASSIST S2 SET, US TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026713917 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention| D