BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24414788 · Received February 23, 2026

    Report

    Report Number
    1220648-2026-03798
    Event Type
    Injury
    Date Received
    February 23, 2026
    Date of Event
    February 13, 2026
    Report Date
    April 8, 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
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D6B UPDATED. THE INVESTIGATION IS STILL ONGOING.

    Additional Manufacturer Narrative · 0

    B5 CLINICAL NARRATIVE UPDATED. H6 CODES WAS UPDATED. SECTION D CATALOG NUMBER WAS CORRECTED. SECTION D BRAND NAME CORRECTED.

    Additional Manufacturer Narrative · 0

    H6 INVESTIGATION: TYPE, FINDINGS, AND CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. THE CAUSE OF THE HIGH PURGE PRESSURE COULD NOT BE DETERMINED AS NO PRODUCT AND INSUFFICIENT LOGS WERE RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    A4 IS UNKNOWN. 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

    UPDATED INFORMATION: B5 NARRATIVE UPDATED. H6 MED DEV PROB CODE REMOVED A141101.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT¿S PURGE FLOW ABRUPTLY DECREASED FROM APPROXIMATELY 10 ML/HR TO 2.5 ML/HR, WITH A CONCURRENT INCREASE IN PURGE PRESSURE TO THE 900S. NO KINKS WERE IDENTIFIED IN THE PURGE SYSTEM. THE CARE TEAM DECIDED TO CHANGE THE PURGE SOLUTION TO A TISSUE PLASMINOGEN ACTIVATOR (TPA). AFTER SEVERAL HOURS, THE PURGE FLOW IMPROVED TO 9.0 ML/HR.

    Description of Event or Problem · 0

    AN IMPELLA 5.5 WAS INSERTED VIA RIGHT AXILLARY ARTERY IN A 64-YEAR-OLD MALE WHO WAS ADMITTED FOR ACUTE MYOCARDIAL INFARCTION WITH CARDIOGENIC SHOCK. THE PATIENT¿S COMORBIDITIES WERE UNKNOWN. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS SCAI STAGE D. THE PATIENT RECEIVED SUPPORT FROM THE 5.5 FOR CORONARY ANGIOPLASTY WITH STENT PLACEMENT. ON DAY 3 OF SUPPORT, THE PATIENT HAD ACUTE KIDNEY INJURY AND A DIALYSIS CATHETER WAS PLACED FOR CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT). RENAL FAILURE IS A KNOWN POTENTIAL ADVERSE EVENT OF THE IMPELLA 5.5 PER THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 0

    UPDATED CLINICAL NARRATIVE: AN IMPELLA 5.5 WAS INSERTED VIA RIGHT AXILLARY ARTERY IN A 64 YEAR OLD MALE WHO WAS ADMITTED FOR ACUTE MYOCARDIAL INFARCTION WITH CARDIOGENIC SHOCK. THE PATIENT¿S COMORBIDITIES WERE UNKNOWN. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS SCAI STAGE D. THE PATIENT RECEIVED SUPPORT FROM THE 5.5 FOR CORONARY ANGIOPLASTY WITH STENT PLACEMENT. ON DAY 3 OF SUPPORT, THE PATIENT HAD ACUTE KIDNEY INJURY AND A DIALYSIS CATHETER WAS PLACED FOR CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT). RENAL FAILURE IS A KNOWN POTENTIAL ADVERSE EVENT OF THE IMPELLA 5.5 PER THE INSTRUCTIONS FOR USE. IT WAS REPORTED THAT THE PATIENT¿S PURGE FLOW ABRUPTLY DECREASED FROM 10¿S TO 2.5ML/HR WITH PURGE PRESSURE INCREASED TO 900¿S. NO KINKS WERE REPORTED IN THE PURGE SYSTEM. THE TEAM DECIDED TO CHANGE THE PURGE SOLUTION TO A TISSUE PLASMINOGEN ACTIVATOR (TPA) SOLUTION OF 2MG ALTEPLASE IN 48ML OF STERILE WATER. AFTER SEVERAL HOURS, THE PURGE FLOW WAS INCREASED TO 9.0 ML/HR. THERE WAS NO NOTED INTERRUPTION OF SUPPORT FOR THE PATIENT. THROMBUS FORMATION CAN CREATE A BLOCKAGE THAT RESTRICTS THE FLOW OF PURGE SOLUTION, AND CAN OCCUR DUE TO INADEQUATE ANTICOAGULATION. THIS IS OFTEN CORRECTED BY USING TPA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47006 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026806228 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1