BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24915703 · Received April 17, 2026

    Report

    Report Number
    1220648-2026-06934
    Event Type
    Injury
    Date Received
    April 17, 2026
    Date of Event
    April 13, 2026
    Report Date
    May 14, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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.

    Description of Event or Problem · 0

    AN IMPELLA 5.5 DEVICE WAS INSERTED VIA A RIGHT AXILLARY/SUBCLAVIAN SURGICAL APPROACH IN A 57-YEAR-OLD MALE PATIENT FOR THE INDICATION OF CARDIOMYOPATHY. THE INTRODUCER WAS PEELED AWAY OUTSIDE THE BODY. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS NOT OTHERWISE SPECIFIED. AFTER TRANSFER TO THE INTENSIVE CARE UNIT (ICU) ON IMPELLA 5.5 SUPPORT, A HEMATOMA WAS IDENTIFIED AT THE AXILLARY CUTDOWN SITE, AS NOTED ON COMPUTED TOMOGRAPHY (CT) IMAGING PER BEDSIDE NURSING REPORT. FOLLOWING, THE CARE TEAM STATED THAT THE HEMATOMA WAS STABLE AND SMALLER COMPARED TO THE PRIOR DAY. THE PATIENT HAD BEEN RECEIVING THERAPEUTIC SYSTEMIC ANTICOAGULATION WITH A HEPARIN INFUSION IN CONJUNCTION WITH A SODIUM BICARBONATE PURGE SOLUTION. FOLLOWING IDENTIFICATION OF THE HEMATOMA, THE HEPARIN INFUSION WAS DISCONTINUED, AND HEMOSTASIS WAS ACHIEVED WITH MANUAL PRESSURE. CONTRIBUTING FACTORS TO THE BLEEDING INCLUDED ANTICOAGULATION THERAPY AND REPORTED UNDERLYING COAGULOPATHY. THE PATIENT REMAINED ON IMPELLA 5.5 SUPPORT AND WAS REPORTED TO BE CLINICALLY STABLE, WITH NO ACUTE IMPELLA-RELATED ISSUES OR CONCERNS NOTED AT THE TIME OF DOCUMENTATION. ACCESS-SITE BLEEDING AND HEMATOMA FORMATION MAY OCCUR IN THE SETTING OF LARGE-BORE AXILLARY ARTERIAL ACCESS AND ARE INFLUENCED BY FACTORS INCLUDING SYSTEMIC ANTICOAGULATION, UNDERLYING COAGULOPATHY, SURGICAL CUTDOWN TECHNIQUE, AND PATIENT-SPECIFIC HEMODYNAMIC CONDITIONS. ANTICOAGULATION AND PURGE REQUIREMENTS ASSOCIATED WITH IMPELLA SUPPORT MAY FURTHER CONTRIBUTE TO IMPAIRED HEMOSTASIS AT THE ACCESS SITE, PARTICULARLY IN CRITICALLY ILL PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533242 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027825355 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1