BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24764932 · Received April 2, 2026

    Report

    Report Number
    1220648-2026-06291
    Event Type
    Death
    Date Received
    April 2, 2026
    Date of Event
    March 25, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS ONE OF TWO RELATED REPORTS. THIS REPORT REPRESENTS THE IMPELLA 5.5 AND ANOTHER REPORT WAS SUBMITTED TO REPRESENT THE IMPELLA CP. THE PRODUCT WAS DISCARDED. 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

    H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION AND ADDED CLINICAL REVIEW. THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA 5.5 DEVICE WAS INSERTED VIA THE RIGHT AXILLARY ARTERY IN A 69-YEAR-OLD MALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS), SCAI SHOCK STAGE D, WITH A HISTORY OF PRIOR CORONARY ARTERY BYPASS GRAFTING, KNOWN CORONARY ARTERY DISEASE, AND DIABETES MELLITUS. THE REGISTERED NURSE REPORTED THAT THE PATIENT HAD BEEN CONSISTENTLY RECEIVING BLOOD PRODUCTS SINCE RETURNING FROM THE OPERATING ROOM. THE PATIENT REQUIRED TRANSFUSIONS FOR A DROP IN HEMOGLOBIN; HOWEVER, THE EXACT SOURCE OF BLEEDING WAS UNCLEAR. AN ADDITIONAL CONTRIBUTING FACTOR WAS UNKNOWN BLEEDING NECESSITATING ONGOING TRANSFUSION SUPPORT. DESPITE CONTINUED MANAGEMENT, THE PATIENT REMAINED IN REFRACTORY CARDIOGENIC SHOCK. AFTER DISCUSSIONS REGARDING PROGNOSIS, THE FAMILY MADE AN INFORMED DECISION TO WITHDRAW CARE. THE PATIENT SUBSEQUENTLY EXPIRED. THE REPORTED MAJOR BLEED IS CONSISTENT WITH PERIOPERATIVE AND ACCESS-SITE¿RELATED BLEEDING COMPLICATIONS IN THE SETTING OF CRITICAL ILLNESS, MECHANICAL CIRCULATORY SUPPORT, AND SYSTEMIC ANTICOAGULATION REQUIREMENTS ASSOCIATED WITH IMPELLA SUPPORT. THE REPORTED CARDIOGENIC SHOCK IS CONSISTENT WITH THE SEVERITY OF THE UNDERLYING AMI/CGS AND PROGRESSIVE HEMODYNAMIC FAILURE DESPITE ADVANCED SUPPORTIVE MEASURES. THE DEVICE WILL BE CONSERVATIVELY REPORTED FOR DEATH; HOWEVER, GIVEN THAT THE PATIENT PRESENTED IN SCAI SHOCK STAGE D WITH REFRACTORY CARDIOGENIC SHOCK, THE DEATH IS MOST CONSISTENT WITH THE SEVERITY OF THE UNDERLYING CRITICAL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825831 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026814418 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention| D