BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24839981 · Received April 10, 2026

    Report

    Report Number
    1220648-2026-06639
    Event Type
    Injury
    Date Received
    April 10, 2026
    Date of Event
    April 3, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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

    B5: ADDED UPDATED INFORMATION

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON COMPLETION OF OUR ANALYSIS, A SUPPLEMENTAL REPORT WILL BE FILED. SECTION D9 HAS BEEN UPDATED.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: A 72 YEAR OLD FEMALE PATIENT WITH A PRE SUPPORT CLINICAL STATE CONSISTENT WITH SCAI SHOCK STAGE E UNDERWENT ELECTIVE PLACEMENT OF AN IMPELLA DEVICE VIA PERCUTANEOUS LEFT FEMORAL ARTERIAL ACCESS. THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM FOR VIDEO ASSISTED THORACOSCOPIC SURGERY (VATS) AND POSITIONED IN THE LEFT LATERAL DECUBITUS POSITION TO ALLOW ACCESS TO THE RIGHT THORACIC CAVITY. SHORTLY AFTER AUTOMATED IMPELLA INITIATION (AIC), THE CONTROLLER, WHICH HAD BEEN PLUGGED IN AND DISPLAYING 100%, UNEXPECTEDLY POWERED OFF. THE AIC WAS RESTARTED BY HOLDING THE POWER BUTTON FOR APPROXIMATELY THREE SECONDS, AFTER WHICH AN ERROR MESSAGE OF ¿IMPELLA FAILURE¿ WAS DISPLAYED. THE IMPELLA WHITE CONNECTOR WAS DISCONNECTED AND RECONNECTED, AND SUPPORT RESUMED AT PRIOR FLOW RATES; HOWEVER, A PLACEMENT SIGNAL WAS NOT OBSERVED. APPROXIMATELY ONE MINUTE LATER, A "CONTROLLER ERROR" ALARM OCCURRED. THE IMPELLA WAS THEN TRANSFERRED TO A DIFFERENT AIC, AFTER WHICH SUPPORT RESUMED AND A PLACEMENT SIGNAL WAS VISUALIZED. THE ORIGINAL AIC SUBSEQUENTLY DISPLAYED MULTIPLE ALARMS INCLUDING "AIR IN PURGE SYSTEM", "IMPELLA STOPPED RETROGRADE FLOW," AND "IMPELLA STOPPED MOTOR CURRENT HIGH," DESPITE NO CATHETER BEING CONNECTED AT THAT TIME. THE CUSTOMER REPORTED THE USE OF BOVIE ELECTROCAUTERY DURING SURGERY AS A POTENTIAL CONTRIBUTING FACTOR. BASED ON THE INFORMATION PROVIDED, THE EVENT INVOLVED AN AIC SHUTDOWN AND RESTART ISSUE WITHOUT REPORTED PATIENT HARM; THE PATIENT REMAINED STABLE ON VA ECMO SUPPORT AND CONTINUES ON IMPELLA SUPPORT AT THE TIME OF REPORTING, AND DEVICE INVOLVEMENT COULD NOT BE CONFIRMED. THE IMPELLA AIC WILL BE CONSERVATIVELY REPORTED FOR HEMODYNAMIC INSTABILITY DUE TO TEMPORARY HEMODYNAMIC SUPPORT INTERRUPTION DURING THE EXCHANGE HOWEVER THE EXCHANGE WAS PERFORMED WITH NO CONSEQUENCE TO THE PATIENT AND SUPPORT WAS RESUMED WITHOUT ANY KNOWN ADVERSE EVENTS.

    Description of Event or Problem · 0

    THE PATIENT DID FINE AS WE SWITCHED TO ANOTHER CONSOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537386 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2011927

    Patients

    Seq Age Sex Outcome Treatment
    1