BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTICAL, AIC, IMPELLA CONNECT, PKGD, US

    MDR report key: 24085765 · Received January 15, 2026

    Report

    Report Number
    1220648-2026-00881
    Event Type
    Death
    Date Received
    January 15, 2026
    Date of Event
    December 27, 2025
    Report Date
    February 17, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502011401
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 UPDATED. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER. THEREFORE, THE INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H5 AND H8 WERE UPDATED. THE CAUSE OF THE CONTROLLER ERROR ALARM WAS A COMMUNICATION ANOMALY BETWEEN THE OPTICAL PRESSURE MEASURING UNIT AND THE MAIN COMPUTER.

    Additional Manufacturer Narrative · 0

    62 YO MALE WITH PLANNED HIGH-RISK SURGERY, SUBSEQUENTLY DEVELOPS POST CARDIOTOMY CARDIOGENIC SHOCK (PCCS) AND LOW CARDIAC OUTPUT SYNDROME (LCOS). PRIOR TO HAVING THE IMPELLA PLACED, THE EJECTION FRACTION (EF) OF 10%, LACTATE OF 0.7, CREATININE OF 1.68, AND IN SHOCK STAGE E. HE WAS INITIALLY PLACED ON EXTRACORPOREAL OXYGENATION (ECMO) AND 48HOURS LATER HAD THE 5.5 FOR VENTING SUPPORT ONLY. THE PATIENT DID NOT IMPROVE AND THE FAMILY DECIDED TO WITHDRAW CARE. THE AUTOMATED IMPELLA CONTROLLER (AIC) PLACEMENT SIGNAL ISSUE WAS IDENTIFIED ON (B)(6) 2025. GIVEN THE WAVEFORM ERROR CORRECTED, THE AIC DID NOT NEED TO BE REPLACED. THE AIC WILL BE CONSERVATIVELY REPORTED. THE PATIENT FAMILY DECIDED TO WITHDRAW CARE A FEW DAYS LATER AND THE PATIENT DIED ON (B)(6) 2025, WHILE ON SUPPORT. DEVICE HAS BEEN RETURNED, D9 HAS BEEN UPDATED ACCORDINGLY. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT DURING IMPELLA SUPPORT WITH A LEFT HEART DEVICE, THE AUTOMATED IMPELLA CONTROLLER (AIC) ALARMED AND SELF-RESOLVED. ON THE THIRD DAY OF IMPELLA SUPPORT, THE NURSE CALLED THE CUSTOMER SUPPORT CENTER TO REPORT THAT THE PLACEMENT SIGNAL AND LEFT VENTRICLE SIGNAL DISAPPEARED FROM THE AIC SCREEN AND THERE WAS A CONTROLLER ALARM. IT WAS REPORTED THAT THE ERROR CLEARED ON ITS OWN WITH NO INTERVENTION. DURING THE PHONE CONVERSATION, THE ALARM OCCURRED TWICE MORE AND SELF-RESOLVED BOTH TIMES. THE ABIOMED SUPPORT TEAM RECOMMENDED TO THE NURSE TO CHECK THE WHITE PLUG CONNECTION AND VERIFY THE PLUG WAS SEATED SECURELY, AND TO HAVE A BACK-UP AIC READY IF THE ERROR RETURNED AND COULD NOT BE RESOLVED. PRIOR TO THE CALL ENDING, THE WAVEFORMS WERE APPROPRIATE AND THERE WERE NO ALARMS. NO SIGNS OR SYMPTOMS OF PATIENT INJURY WERE REPORTED, THERE WAS NO REPORTED HARM ASSOCIATED WITH THE EVENT. IT WAS NOTED THAT THE PATIENT'S OUTCOME AT EXPLANT WAS EXPIRED. ADDITIONAL CLINICAL DETAILS, INCLUDING PERIOPERATIVE COURSE, CONTRIBUTING FACTORS, AND CAUSE OF DEATH, WERE UNAVAILABLE AT THE TIME OF REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148012 OPTICAL, AIC, IMPELLA CONNECT, PKGD, US TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 1558681 00813502011401

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Death