BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25184683 · Received May 15, 2026

    Report

    Report Number
    1220648-2026-07904
    Event Type
    Injury
    Date Received
    May 15, 2026
    Date of Event
    May 7, 2026
    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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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

    THIS FOLLOW-UP MDR IS BEING SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION RECEIVED FROM THE SALES REPRESENTATIVE. THE SALES REPRESENTATIVE INDICATED THAT THE DEVICE IS EXPECTED TO BE RETURNED TO THE MANUFACTURER FOLLOWING EXPLANT, AS THE CLINICAL TEAM HAS BEEN INFORMED THAT THE DEVICE SHOULD BE SENT IN FOR EVALUATION.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA 5.5 WAS INSERTED VIA A RIGHT AXILLARY SURGICAL APPROACH IN A 72-YEAR-OLD FEMALE FOR POST-CARDIOTOMY CARDIOGENIC SHOCK (PCCS), PRESENTING IN SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) STAGE E SHOCK. WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT, A REGISTERED NURSE (RN) INQUIRED ABOUT THE POTENTIAL EFFECT OF LACTATED RINGER¿S (LR) SOLUTION ON PUMP MOTOR FUNCTION AND REPORTED THAT THE IMPELLA 5.5 HAD BEEN PRIMED INTRAOPERATIVELY IN THE CARDIOVASCULAR OPERATING ROOM WITH LACTATED RINGER¿S AND SODIUM BICARBONATE. THE RN STATED THAT THE PURGE FLUID BAG CONTAINING LR AND BICARBONATE HAD BEEN RUNNING FOR APPROXIMATELY 12 HOURS, AND THIS WAS IDENTIFIED DURING A ROUTINE PURGE BAG CHANGE. SUBSEQUENTLY, A HIGH PURGE PRESSURE ALARM (HPP) WAS OBSERVED. THE INTENSIVIST INITIATED A TISSUE PLASMINOGEN ACTIVATOR (TPA) PROTOCOL FOR MANAGEMENT OF ELEVATED PURGE PRESSURE. THE TPA WAS UTILIZED FOR THE HPP TO MITIGATE IMPACT OF BIOMATERIAL WITHIN THE MOTOR AND THERE WAS NO IMPACT ON THE PATIENT. THE PATIENT SURVIVED TO EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442052 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027827667 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1