BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 25095692 · Received May 6, 2026

    Report

    Report Number
    1220648-2026-07582
    Event Type
    Death
    Date Received
    May 6, 2026
    Date of Event
    April 30, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 WAS PROVIDED B5 WAS UPDATED AND H6 F2303 AND F19 WAS ADDED.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: THE IMPELLA 5.5 WAS INSERTED VIA THE DIRECT SURGICAL ACCESS FOR THE 63 YEAR OLD MALE PATIENT WHO HAD BEEN ADMITTED IN FOR VALVE SURGERY/BENTALL PROCEDURE AND HAD THE 5.5 PLACED ELECTIVELY TO SUPPORT. THE PATIENT WAS IN SCAI STAGE E SHOCK AT THE PUMP INSERTION. UNDERLYING MEDICAL HISTORY WAS NOT SHARED. THE PATIENT SUFFERED FROM BLEEDING AFTER THE TRANSFER FROM OPERATING SUITE TO THE ICU VIA THE MEDIASTINAL CHEST TUBES. BLEEDING IN THIS CLINICAL CONTEXT IS A KNOWN AND EXPECTED RISK ASSOCIATED WITH IMPELLA 5.5 SUPPORT, PARTICULARLY IN THE SETTING OF RECENT MAJOR CARDIAC SURGERY, DIRECT SURGICAL AORTIC ACCESS, PERIOPERATIVE COAGULOPATHY, AND CRITICAL ILLNESS. THE TEAM WITHDREW CARE AND THE PATIENT EXPIRED AFTER JUST OVER 2 DAYS OF SUPPORT. THE DEATH IS BEING REPORTED ALTHOUGH AN UNLIKELY CONTRIBUTING FACTOR TO THE DEATH, AND MORE LIKELY THE PATIENT'S PRESENTING NATIVE CRITICAL CONDITION AS PRESENTED IN SCAI STAGE E.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: THE IMPELLA 5.5 WAS INSERTED VIA THE DIRECT SURGICAL ACCESS FOR THE 63 YEAR OLD MALE PATIENT WHO HAD BEEN ADMITTED IN FOR VALVE SURGERY/BENTALL PROCEDURE AND HAD THE 5.5 PLACED ELECTIVELY TO SUPPORT. THE PATIENT WAS IN SCAI STAGE E SHOCK AT THE PUMP INSERTION. UNDERLYING MEDICAL HISTORY WAS NOT SHARED. THE PATIENT SUFFERED FROM BLEEDING AFTER THE TRANSFER FROM OPERATING SUITE TO THE ICU VIA THE MEDIASTINAL CHEST TUBES. BLEEDING IN THIS CLINICAL CONTEXT IS A KNOWN AND EXPECTED RISK ASSOCIATED WITH IMPELLA 5.5 SUPPORT, PARTICULARLY IN THE SETTING OF RECENT MAJOR CARDIAC SURGERY, DIRECT SURGICAL AORTIC ACCESS, PERIOPERATIVE COAGULOPATHY, AND CRITICAL ILLNESS. THE TEAM WITHDREW CARE AND THE PATIENT EXPIRED AFTER JUST OVER 2 DAYS OF SUPPORT. THE DEATH IS BEING REPORTED ALTHOUGH AN UNLIKELY CONTRIBUTING FACTOR TO THE DEATH, AND MORE LIKELY THE PATIENT'S PRESENTING NATIVE CRITICAL CONDITION AS PRESENTED IN SCAI STAGE E. THE TEAM DID REPORT THE BLEEDING WAS A SIGNIFICANT FACTOR IN THIS PATIENT'S CLINICAL COURSE. THE PHYSICIAN STATED THAT BLEEDING WAS IDENTIFIED SOMEWHERE IN THE RIGHT ATRIUM WHEN THE PATIENT WAS TAKEN BACK TO THE OR HOURS AFTER THE INITIAL PROCEDURE. THE PATIENT RETURNED TO THE ICU WITH AN OPEN CHEST AND RECEIVED MASS TRANSFUSION WHILE IN THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72877 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026658517 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1