BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24410278 · Received February 21, 2026

    Report

    Report Number
    1220648-2026-03720
    Event Type
    Death
    Date Received
    February 21, 2026
    Date of Event
    October 29, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    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

    ADDED: B5 BASED ON NEW ADDITIONAL INFORMATION RECEIVED. CORRECTED: H5 (LABELED FOR SINGLE USE). 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

    CORRECTED INFORMATION WAS PROVIDED IN B2 (IS REQUIRED INTERVENTION). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY OMITTED FROM THE INITIAL REPORT. CORRECTED INFORMATION WAS PROVIDED IN D1 (BRAND NAME). H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. THE ROOT CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    A 76-YEAR-OLD MALE WITH DECOMPENSATED SEVERE MITRAL REGURGITATION PRESENTED IN CARDIOGENIC SHOCK WITH ASSOCIATED PULMONARY FAILURE AND WAS INITIATED ON ECLS. AN IMPELLA 5.5 IMPLANT WAS PLANNED TO SUPPORT THE PATIENT DURING HIGH-RISK CARDIAC SURGERY (MITRAL VALVE REPLACEMENT). THIS WAS A HIGHLY COMPLEX PERIOPERATIVE COURSE. POSTOPERATIVELY AND THROUGHOUT IMPELLA SUPPORT, THE PATIENT EXPERIENCED REPEATED EPISODES OF REQUIRING RE-INTUBATION AND EXTUBATION DUE TO SECRETION MANAGEMENT ISSUES AND FLUCTUATING LEVELS OF RESPONSIVENESS. THE PATIENT ALSO DEVELOPED POSITIVE BLOOD CULTURES FROM AN UNIDENTIFIED SOURCE. NO ADDITIONAL CLINICAL DETAILS REGARDING DIAGNOSTICS OR SOURCE CONTROL WERE PROVIDED. GIVEN THE LIMITED INFORMATION AVAILABLE, THE FATAL OUTCOME IS BEING CONSERVATIVELY REPORTED. CARE WAS ULTIMATELY WITHDRAWN IN THE CONTEXT OF THE PATIENT¿S OVERALL CRITICAL AND HIGHLY COMPLEX CONDITION.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION INDICATES THAT THE PATIENT WAS TREATED WITH BROAD SPECTRUM ANTIBIOTICS WHICH RESOLVED THE INFECTION. DEVICE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18850 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026729448 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Death| R