BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24552486 · Received March 9, 2026

    Report

    Report Number
    1220648-2026-04824
    Event Type
    Injury
    Date Received
    March 9, 2026
    Date of Event
    October 2, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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

    HEALTH EFFECT - CLINICAL CODE E1302 NO LONGER APPLIABLE TO THIS REPORT.

    Description of Event or Problem · 0

    A 66-YEAR-OLD MALE WITH A PAST MEDICAL HISTORY SIGNIFICANT FOR CORONARY ARTERY DISEASE WITH PRIOR PERCUTANEOUS CORONARY INTERVENTION, SEVERE MITRAL REGURGITATION, HYPERTENSION, HYPERLIPIDEMIA, AND TYPE II DIABETES MELLITUS PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF SHORTNESS OF BREATH AND LETHARGY. ON ARRIVAL, THE PATIENT APPEARED SHOCKY AND WAS COLD, CLAMMY, AND DIAPHORETIC. HE WAS ADMITTED TO THE MEDICAL INTENSIVE CARE UNIT (MICU), WHERE HIS CLINICAL CONDITION RAPIDLY DETERIORATED. THE MEDICAL TEAM DECIDED TO PLACE AN IMPELLA CP FOR HEMODYNAMIC SUPPORT. THE FEMORAL ARTERY WAS FREE OF DISEASE BUT NOTED TO BE SLIGHTLY NARROW; HOWEVER, THE TEAM PROCEEDED WITH INSERTION AND THE IMPELLA DEVICE WAS SUCCESSFULLY IMPLANTED. THE PHYSICIAN THEN PERFORMED A LEFT HEART CATHETERIZATION VIA SINGLE ARTERIAL ACCESS, WHICH DEMONSTRATED THAT ALL CORONARY VESSELS WERE PATENT. AN ANGIOGRAM PERFORMED THROUGH THE REPOSITIONING SHEATH SUBSEQUENTLY DEMONSTRATED SLOW BLOOD FLOW TO THE ACCESS-SITE LEG. A TRIALYSIS CATHETER WAS PLACED, AND THE PATIENT WAS TRANSFERRED BACK TO THE MICU FOR CONTINUED MONITORING. UPON ARRIVAL IN THE INTENSIVE CARE UNIT, THE PATIENT CONTINUED TO HAVE NEITHER A PALPABLE NOR DOPPLER-DETECTABLE PULSE IN THE ACCESS-SITE LEG. THE TREATING PHYSICIANS ANTICIPATED IMPROVEMENT AS VASOPRESSOR MEDICATIONS WERE REDUCED. THE PATIENT¿S URINE OUTPUT WAS INITIALLY CLEAR BUT LATER BECAME BLOODY. THE PHYSICIAN ATTRIBUTED THIS FINDING TO THE DEVICE OPERATING AT MAXIMUM FLOW SPEED AND SUSPECTED IT REPRESENTED OLDER HEMOLYSIS. DUE TO THE PATIENT¿S ONGOING NEED FOR INCREASED HEMODYNAMIC SUPPORT AND THE CONTINUED ABSENCE OF PULSES IN THE AFFECTED LEG, THE DECISION WAS MADE TO ESCALATE SUPPORT TO AN IMPELLA 5.5 DEVICE. THE IMPELLA 5.5 WAS SUCCESSFULLY IMPLANTED, THE IMPELLA CP DEVICE WAS REMOVED, AND THE PATIENT WAS RETURNED TO THE INTENSIVE CARE UNIT FOR FURTHER MANAGEMENT. NO DEVICE MALFUNCTION WAS REPORTED, AND ALL DEVICE-RELATED ACTIONS WERE TAKEN BASED ON THE PATIENT¿S CLINICAL CONDITION AND PROCEDURAL FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464563 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026696360 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1