BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 25015074 · Received April 28, 2026

    Report

    Report Number
    1220648-2026-07167
    Event Type
    Death
    Date Received
    April 28, 2026
    Date of Event
    March 31, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDED D3 MANUFACTURER FAX WAS OMITTED DURING INITIAL REPORT. CORRECTED D4 SERIAL NUMBER. H6 INVESTIGATION: TYPE, FINDINGS, AND CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE CAUSE OF THE LOW PUMP FLOW WAS NOT DETERMINED DUE TO NO PRODUCT RETURNED, INCONCLUSIVE DATA LOG REVIEW, AND INSUFFICIENT CLINICAL DETAILS. THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    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

    CLINICAL NARRATIVE: AN IMPELLA 5.5 DEVICE WAS INSERTED VIA THE LEFT AXILLARY ARTERY IN A 77-YEAR-OLD MALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS). THE PATIENT¿S COMORBIDITIES WERE UNKNOWN. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS IDENTIFIED AS SCAI SHOCK STAGE A. THE PATIENT, WHO HAD BEEN SUPPORTED BY AN IMPELLA 5.5 SINCE JANUARY 23RD, DEVELOPED ATRIOVENTRICULAR (AV) BLOCK ON THE NIGHT OF MARCH 31ST. THE SUPPORT LEVEL WAS CHANGED FROM P2 TO P4 TO INCREASE THE ASSIST FLOW RATE. THE MOTOR WAVEFORM VALUE SUDDENLY DROPPED TO AROUND 100. THE LEVEL WAS RETURNED TO P2, BUT THE MOTOR WAVEFORM VALUE DID NOT CHANGE. A CARE POLICY WAS ADOPTED FOR THE PATIENT, AND NO OTHER TREATMENT WAS GIVEN. THE INTENDED ASSISTIVE FLOW WAS NOT ACHIEVED. THE PATIENT HAD PRE-EXISTING POOR CARDIAC FUNCTION AND SUBSEQUENTLY DIED ON SUPPORT. THE PHYSICIAN WAS AWARE OF THE RISK OF PUMP FAILURE DUE TO EXCEEDING THE RECOMMENDED DURATION OF SUPPORT AND REQUESTED DATA LOG ANALYSIS REGARDING WHETHER THE IMPELLA PUMP FAILED IN THIS CASE, AS WELL AS TRENDS IN THE MOTOR WAVEFORM AND VARIOUS PARAMETERS (MOTOR CURRENT, PURGE PRESSURE, FLOW RATE, ETC.) WHEN THE IMPELLA PUMP IS NEARING THE END OF ITS LIFESPAN. THE RELATIONSHIP BETWEEN MOTOR WAVEFORM, ATRIOVENTRICULAR BLOCK, IMPELLA, AND DEATH WAS UNKNOWN. THE CAUSE OF DEATH WAS NOTED TO BE DUE TO MULTIPLE ORGAN FAILURE. ALTHOUGH THE INTENDED FLOW WAS NOT ACHIEVED, THE IMPELLA WAS FUNCTIONING WITHOUT PROBLEMS AT THE TIME OF THE PATIENT'S DEATH. THE HEART BLOCK MAY BE RELATED TO THE PATIENT¿S UNDERLYING CARDIAC CONDITION, PROGRESSION OF DISEASE, OR PERIOPERATIVE FACTORS. THE DEVICE WILL BE CONSERVATIVELY REPORTED FOR DEATH; HOWEVER, THE DEATH IS MOST LIKELY ATTRIBUTED TO THE PATIENT'S UNDERLYING CRITICAL CLINICAL CONDITION, PRE-EXISTING POOR CARDIAC FUNCTION AND MULTI-ORGAN FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405095 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026782175

    Patients

    Seq Age Sex Outcome Treatment
    1