BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5 WITH SMARTASSIST S2 SET, US

    MDR report key: 24473857 · Received February 27, 2026

    Report

    Report Number
    1220648-2026-04257
    Event Type
    Injury
    Date Received
    February 27, 2026
    Date of Event
    December 20, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    ADDITIONAL INFORMATION HAS BEEN PROVIDED IN B5 (EVENT DESCRIPTION), INCLUDING FURTHER DETAIL REGARDING RESOLUTION AD INTERVENTION. 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.

    Description of Event or Problem · 0

    A FORTY-SIX-YEAR-OLD MALE PATIENT WITH A MEDICAL HISTORY OF CORONARY ARTERY DISEASE RECEIVED AN IMPELLA CP DEVICE FOR ACUTE HEART FAILURE SECONDARY TO NON-ISCHEMIC CARDIOMYOPATHY. PRIOR TO DEVICE PLACEMENT, THE PATIENT WAS RECEIVING ONE INTRAVENOUS MEDICATION TO SUPPORT HEART MUSCLE CONTRACTION. DUE TO THE ANTICIPATED NEED FOR PROLONGED MECHANICAL CIRCULATORY SUPPORT, THE PATIENT WAS ESCALATED TO AN IMPELLA 5.5 DEVICE IN THE OPERATING ROOM THE FOLLOWING DAY. ON THE FOURTH DAY OF IMPELLA 5.5 SUPPORT, AN INTERMITTENT LOSS OF PLACEMENT SIGNAL AND LEFT VENTRICULAR WAVEFORM TRACINGS OCCURRED WITHOUT PATIENT MOVEMENT. MOTOR CURRENT REMAINED PULSATILE AND DEVICE FLOW WAS NOT AFFECTED. THE ISSUE RESOLVED SPONTANEOUSLY AND HAD NO ADVERSE CLINICAL IMPACT. ON THE SAME DAY, A NURSE ALSO NOTICED A STABLE HEMATOMA ON AXILLARY INSERTION SITE THAT DID NOT REQUIRE ANY SURGICAL INTERVENTION. FURTHER TECHNICAL ASSESSMENT WILL BE COMPLETED BY THE ENGINEERING TEAM. AFTER SEVENTEEN DAYS OF IMPELLA SUPPORT, THE PATIENT WAS SUCCESSFULLY BRIDGED TO HEART TRANSPLANTATION AND THE IMPELLA 5.5 DEVICE WAS REMOVED. CP TO 5.5 ESCALATION. TWO CIS FOR 5.5. 53035, 53010. BOTH 5.5.

    Description of Event or Problem · 0

    YES, ALL INTERVENTIONS WERE PERFORMED TO ADDRESS THE ALLEGED COMPLAINT EVENT INCLUDING CALLING THE CSC. THE WAVEFORM WAS INTERMITTENT AND DID NOT AFFECT PATIENT CARE. THE DEVICE IS NOT AVAILABLE FOR RETURN TO MY KNOWLEDGE. THAT PATIENT WAS PLANNED TO GO FOR HEART TRANSPLANT WHERE THE PUMP WOULD HAVE BEEN REMOVED AND DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92715 IMPELLA 5.5 WITH SMARTASSIST S2 SET, US TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026794861 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1