BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5 WITH SMARTASSIST S2 SET, US

    MDR report key: 24579985 · Received March 12, 2026

    Report

    Report Number
    1220648-2026-05079
    Event Type
    Injury
    Date Received
    March 12, 2026
    Date of Event
    December 7, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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.

    Description of Event or Problem · 0

    A SIXTY-TWO-YEAR-OLD MALE PATIENT RECEIVED AN IMPELLA 5.5 DEVICE FOR MANAGEMENT OF ACUTE MYOCARDIAL INFARCTION CARDIOGENIC SHOCK FOLLOWING PERCUTANEOUS CORONARY INTERVENTION. THE PATIENT WAS SUPPORTED WITH AN INTRA-AORTIC BALLOON PUMP, MECHANICAL VENTILATION, AND THREE INOTROPIC MEDICATIONS BEFORE IMPELLA IMPLANTATION, CONSISTENT WITH STAGE E OF THE SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS SHOCK CLASSIFICATION AND HAD ALSO UNDERGONE CARDIOPULMONARY RESUSCITATION PRIOR TO DEVICE PLACEMENT. AFTER IMPELLA IMPLANTATION, THE PATIENT DEMONSTRATED SIGNIFICANT HEMODYNAMIC IMPROVEMENT, AND AFTER FOUR DAYS OF SUPPORT THE PATIENT ACHIEVED NATIVE HEART RECOVERY AND THE DEVICE WAS SUCCESSFULLY EXPLANTED. ON THE FIRST DAY OF IMPELLA SUPPORT, SYSTEMIC HEPARIN WAS BRIEFLY HELD BY THE TREATING PHYSICIAN DUE TO CONCERN FOR A POSSIBLE CEREBRAL BLEED, ALTHOUGH NO ADDITIONAL INFORMATION WAS AVAILABLE TO CONFIRM THIS SUSPECTED DIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227881 IMPELLA 5.5 WITH SMARTASSIST S2 SET, US TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026732614 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention