BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA 5.5 WITH SMARTASSIST S2 SET, US

    MDR report key: 24615914 · Received March 17, 2026

    Report

    Report Number
    1220648-2026-05411
    Event Type
    Death
    Date Received
    March 17, 2026
    Date of Event
    March 5, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A4 IS UNKNOWN. 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

    AN IMPELLA 5.5 DEVICE WAS INSERTED VIA THE RIGHT AXILLARY ARTERY IN A 73-YEAR-OLD MALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS), SCAI SHOCK STAGE D, WITH A HISTORY OF CORONARY ARTERY DISEASE AND DIABETES MELLITUS. THE PATIENT DEVELOPED BLEEDING AROUND THE AXILLARY ACCESS SITE AND ALSO EXPERIENCED A BRONCHIAL BLEED AND A STROKE. THE HEART-FAILURE PHYSICIAN INDICATED THESE COMPLICATIONS WERE LIKELY RELATED TO THE ECMO DEVICE THAT HAD BEEN IN PLACE. THE LAST RECORDED APTT WAS ELEVATED AT 89, WHICH LIKELY CONTRIBUTED TO THE BLEEDING EVENTS. A PULMONARY EMBOLISM HAD BEEN REMOVED THE PRIOR DAY. HEPARIN WAS SUBSEQUENTLY DISCONTINUED. CARE WAS LATER WITHDRAWN, AND THE PATIENT EXPIRED. THE REPORTED EVENTS ARE MAJOR BLEED, STROKE, PULMONARY EMBOLISM, AND DEATH. THE MAJOR BLEED IS CONSISTENT WITH ACCESS-SITE AND ANTICOAGULATION-RELATED COMPLICATIONS IN THE SETTING OF MECHANICAL CIRCULATORY SUPPORT AND ELEVATED APTT. THE REPORTED STROKE AND PULMONARY EMBOLISM ARE CONSISTENT WITH THE PATIENT¿S UNDERLYING CRITICAL CONDITION AND COMPLEX CLINICAL COURSE. THE PATIENT¿S DEATH IS MOST CONSISTENT WITH THE SEVERITY OF THE UNDERLYING AMI/CGS AS THEY PRESENTED IN CAI SHOCK STAGE D AND MULTISYSTEM COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680328 IMPELLA 5.5 WITH SMARTASSIST S2 SET, US TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026780978 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Death