BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA 5.5 WITH SMARTASSIST S2 SET, US

    MDR report key: 24158492 · Received January 23, 2026

    Report

    Report Number
    1220648-2026-01369
    Event Type
    Death
    Date Received
    January 23, 2026
    Date of Event
    December 6, 2025
    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
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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: NO PRODUCT OR DATA LOGS WERE RETURNED FOR EVALUATION. MAJOR BLEED: CLINICAL DETAILS NOTED PATIENT HAD GASTROINTESTINAL (GI BLEED). THE CAUSE OF THE GI BLEED WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. HIGH PURGE PRESSURE: CLINICAL DETAILS NOTED ELEVATED PURGE PRESSURES AND DECREASED PURGE FLOW ALARMS. NO KINKS IN LINE OBSERVED. NO ADDITIONAL DETAILS PROVIDED. THE CAUSE OF THE HIGH PURGE PRESSURE COULD NOT BE DETERMINED AS NO PRODUCT OR LOGS WERE RETURNED FOR EVALUATION AND LIMITED CLINICAL DETAILS WERE PROVIDED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN PROVIDED IN D4 (PRIMARY UDI NUMBER) AND H4. THIS REPORT IS SUBMITTED AS A FOLLOW UP TO PROVIDE ADDITIONAL INFORMATION OBTAINED AFTER THE INITIAL MDR SUBMISSION. 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

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER; THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT A MALE PATIENT RECEIVED A MECHANICAL CIRCULATORY SUPPORT DEVICE FOLLOWING VALVULAR HEART SURGERY FOR MANAGEMENT OF CARDIOGENIC SHOCK WITH LOW CARDIAC OUTPUT. BEFORE PLACEMENT OF THE DEVICE, THE PATIENT HAD BEEN SUPPORTED WITH AN INTRA-AORTIC BALLOON PUMP, EXTRACORPOREAL MEMBRANE OXYGENATION, AND MULTIPLE INOTROPIC AND VASOPRESSOR MEDICATIONS. DURING SUPPORT WITH THE DEVICE, THE PATIENT DEVELOPED GASTROINTESTINAL BLEEDING, WHICH MAY HAVE BEEN ASSOCIATED WITH SYSTEMIC ANTICOAGULATION THERAPY REQUIRED FOR DEVICE USE. THE PATIENT ALSO EXPERIENCED ELEVATED PURGE PRESSURES AND DECREASED PURGE FLOW ALARMS, ALTHOUGH NO KINKS IN THE PURGE LINE WERE OBSERVED. THE PURGE SOLUTION WAS CHANGED FROM A SODIUM BICARBONATE¿BASED SOLUTION TO A HEPARIN-BASED SOLUTION WITHOUT INTERRUPTION OF HEMODYNAMIC SUPPORT. DUE TO THE SEVERITY OF THE UNDERLYING CONDITION AND IN ACCORDANCE WITH THE FAMILY¿S WISHES, MECHANICAL SUPPORT WAS WITHDRAWN, AND THE PATIENT DIED. THE DEATH WILL BE CONSERVATIVELY REPORTED FOR THE MECHANICAL CIRCULATORY SUPPORT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219834 IMPELLA 5.5 WITH SMARTASSIST S2 SET, US TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 IMPELLA 5.5 WITH SMARTASSIST S2 SET, US 2026688405 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention| D