BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24410353 · Received February 21, 2026

    Report

    Report Number
    1220648-2026-03727
    Event Type
    Injury
    Date Received
    February 21, 2026
    Date of Event
    October 30, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    CORRECTED INFORMATION HAS BEEN PROVIDED IN B5, D1. PPAE (CARDIAC TAMPONADE/MAJOR BLEED/HYPOVOLAEMIA): THE ROOT CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    A 43-YEAR-OLD MALE WITH MORBID OBESITY WAS ADMITTED WITH PROGRESSIVE SHORTNESS OF BREATH. HE WAS DIAGNOSED WITH MULTIVESSEL CORONARY ARTERY DISEASE AND A LEFT VENTRICULAR EJECTION FRACTION OF 20%. THE PATIENT WAS SCHEDULED FOR HIGH-RISK CABG ×3 WITH ELECTIVE IMPELLA 5.5 IMPLANTATION FOR PERIOPERATIVE HEMODYNAMIC SUPPORT. POSTOPERATIVELY, THE PATIENT REQUIRED TWO RE-OPERATIONS FOR CARDIAC TAMPONADE AND BLEEDING. ALTHOUGH TRANSFUSIONS ARE LIKELY IN THE CONTEXT OF REPEATED SURGICAL INTERVENTIONS, NO DOCUMENTATION REGARDING BLOOD PRODUCT ADMINISTRATION WAS PROVIDED. TWO DAYS AFTER THE FINAL RE-OPERATION, THE PATIENT EXPERIENCED FLUID IMBALANCE, WHICH LED TO SUCTION EVENTS AND REQUIRED VOLUME RESUSCITATION. THE SUBSEQUENT COURSE OF IMPELLA SUPPORT WAS UNEVENTFUL. AFTER EIGHT DAYS OF SUPPORT, THE PATIENT WAS SUCCESSFULLY WEANED, WITH IMPROVEMENT IN LEFT VENTRICULAR EJECTION FRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449618 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026721349 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1