BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA 5.5 WITH SMARTASSIST S2 SET, US

    MDR report key: 24344401 · Received February 16, 2026

    Report

    Report Number
    1220648-2026-03243
    Event Type
    Death
    Date Received
    February 16, 2026
    Date of Event
    December 15, 2024
    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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION HAS BEEN PROVIDED IN B1 (IS PRODUCT PROBLEM). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY OMITTED IN ERROR IN THE INITIAL REPORT. 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

    A SIXTY-SIX-YEAR-OLD MALE PATIENT WITH A MEDICAL HISTORY OF TYPE 2 DIABETES MELLITUS, HYPERTENSION, ATRIOVENTRICULAR NODAL REENTRY TACHYCARDIA, AND CARDIOMYOPATHY WITH AN EJECTION FRACTION OF TEN TO FIFTEEN PERCENT PRESENTED WITH THREE WEEKS OF CHEST PRESSURE AND PERSISTENT EPISODES OF VENTRICULAR TACHYCARDIA. THE PATIENT WAS PLACED ON LEFT ATRIAL VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION FOR A PLANNED VENTRICULAR TACHYCARDIA ABLATION; HOWEVER, THE CLINICAL TEAM ELECTED NOT TO PROCEED WITH THE ABLATION AND INSTEAD DECANNULATED AND IMPLANTED AN IMPELLA 5.5 DEVICE VIA AXILLARY ARTERY SURGICAL CUTDOWN WITH THE EVENTUAL GOAL OF EVALUATION FOR HEART TRANSPLANTATION. FOLLOWING IMPLANTATION, THE PATIENT DEMONSTRATED SIGNIFICANT HEMODYNAMIC IMPROVEMENT, THOUGH INTERMITTENT VENTRICULAR TACHYCARDIA EPISODES PERSISTED AND WERE CONTROLLED WITH ANTI-ARRHYTHMIC MEDICATIONS. ON THE NINTH DAY OF IMPELLA SUPPORT, THE PATIENT EXPERIENCED A MASSIVE STROKE RESULTING IN SEVERE NEUROLOGICAL DEFICITS AND IMPAIRED RESPIRATORY FUNCTION. IN LIGHT OF THE GRAVE PROGNOSIS, THE FAMILY ELECTED TO WITHDRAW CARE, AND THE PATIENT EXPIRED WHILE ON SUPPORT. THE IMPELLA 5.5 WILL BE CODED FOR STROKE AND DEATH AS A CONTRIBUTION OF THE PUMP CANNOT BE RULED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406047 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 2025564031 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention| D