BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24895278 · Received April 16, 2026

    Report

    Report Number
    1220648-2026-06868
    Event Type
    Death
    Date Received
    April 16, 2026
    Date of Event
    April 9, 2026
    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
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4. CATALOG AND SERIAL CORRECTED. H6. MEDICAL DEVICE PROBLEM CODE A141102 INCREASE IN PRESSURE REMOVED AND REPLACED WITH A01 PATIENT DEVICE INTERACTION PROBLEM. H6: INVESTIGATION: TYPE, FINDINGS, CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION/ANALYSIS OF THE DEVICE WAS NOT POSSIBLE. THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    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

    B1: ADDED PRODUCT PROBLEM, THIS WAS OMITTED FROM THE INITIAL IN ERROR. ADDITIONAL INFORMATION: THE DEVICE IS NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 0

    AN 88-YEAR-OLD FEMALE WITH POSTCARDIOTOMY CARDIOGENIC SHOCK (PCCS), PRE-SUPPORT CLINICAL STATE CONSISTENT WITH SCAI SHOCK STAGE D, WAS SUPPORTED WITH AN IMPELLA 5.5 DEVICE IMPLANTED ON (B)(6) 2026 AT 22:10 VIA DIRECT RIGHT-SIDED SURGICAL AORTIC ACCESS. THE PATIENT EXPERIENCED RENAL FAILURE REQUIRING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) FOR URINARY OUTPUT MANAGEMENT AND DEVELOPED HEMATURIA WITH URINARY OUTPUT LESS THAN 30 ML/HR, DESCRIBED AS PINK/RED IN COLOR. CARE WAS SUBSEQUENTLY WITHDRAWN, NOT DUE TO THE EVENT, AND THE PATIENT EXPIRED ON (B)(6) 2026 AT 12:50 PM, WHICH CORRESPONDED WITH DEVICE EXPLANT. BASED ON AVAILABLE INFORMATION, THE PATIENT EXPIRED FOLLOWING WITHDRAWAL OF CARE IN THE SETTING OF SEVERE CARDIOGENIC SHOCK AND MULTISYSTEM COMPLICATIONS. HEMATURIA AND RENAL FAILURE MAY HAVE BE CONTRIBUTED TO THE PATIENT UNDERLYING CRITICAL ILLNESS. THE DEATH IS CONSERVATIVELY BEING REPORTED TO THE IMPELLA 5.5 BUT IS UNLIKELY RELATED AND IS MOST LIKELY ATTRIBUTED TO PATIENTS UNDERLYING CRITICAL CONDITION AS THEY PRESENTED IN SCAI STAGE D SHOCK ON MULTIPLE INOTROPES AND PRESSORS AND WAS VENTILATED FOR RESPIRATORY SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297892 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027824151 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1