BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24712474 · Received March 30, 2026

    Report

    Report Number
    1220648-2026-06020
    Event Type
    Death
    Date Received
    March 30, 2026
    Date of Event
    March 20, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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

    H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION AND ADDED CLINICAL REVIEW. CORRECTED INFORMATION HAS BEEN PROVIDED IN D3 (MANUFACTURER FAX); D4 (SERIAL); E1; E3. THE CAUSE OF THE DEVICE IN WRONG POSITION CANNOT BE ESTABLISHED. THE CAUSE OF THE HEMOLYSIS/MECHANICAL INTERACTION WITH BLOOD CANNOT BE ESTABLISHED.

    Additional Manufacturer Narrative · 0

    B2 SELECTION WAS ADDED DUE TO NEW INFORMATION RECEIVED. B5 ADDITIONAL INFORMATION WAS RECEIVED AND ADDED. H6 HEALTH EFFECT - IMPACT CODE WAS ADDED. DUE TO NEW INFORMATION THAT WAS RECEIVED.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA CP DEVICE WAS INSERTED INTO THE RIGHT FEMORAL ARTERY IN A 87-YEAR-OLD FEMALE PATIENT WITH A PAST MEDICAL HISTORY OF CORONARY ARTERY DISEASE (CAD) AND DIABETES, PRESENTING IN ACUTE MYOCARDIAL INFARCTION (AMI) AND CARDIOGENIC SHOCK (CGS), IN SCAI STAGE D SHOCK, ON MULTIPLE INOTROPES AND VASOPRESSORS, AND ON A VENTILATOR FOR RESPIRATORY SUPPORT, PRIOR TO INITIATION OF SUPPORT. WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), THE IMPELLA WAS PLACED POST-TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). TAVR DEPLOYMENT FAILED AND THE TAVR VALVE WAS SUSPECTED TO BE IN THE SINUS. HEMOLYSIS WAS NOTED DUE TO POOR POSITION. THERE WERE ERRONEOUS IMPELLA IN AORTA ALARMS WITH LARGE VOLUME SHIFTS AND CHANGES IN HEMODYNAMICS. POSITION CONFIRMED BY ECHOCARDIOGRAM. THE FOLLOWING DAY AFTER IMPELLA INSERTION, THE FAMILY WITHDREW CARE, AND THE PATIENT EXPIRED ON SUPPORT. THE IMPELLA FUNCTIONED AT P-9 AT 3.8L/MIN AS INTENDED. HEMOLYSIS MAY BE INFLUENCED BY PATIENT-SPECIFIC FACTORS SUCH AS CRITICAL ILLNESS, UNDERLYING CARDIAC DYSFUNCTION, HEMODYNAMIC INSTABILITY, AND POTENTIAL DEVICE POSITION. THE IMPELLA IS CONSERVATIVELY BEING REPORTED FOR DEATH; HOWEVER, IS UNLIKELY TO HAVE CONTRIBUTED TO THE PATIENT'S DEATH, WHICH WAS MOST LIKELY DUE TO THE CLINICAL CONDITION OF A CRITICALLY ILL PATIENT IN ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, COMPLICATED BY STAGE D SHOCK.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED. THE PUMP WAS ATTEMPTED TO BE REPOSITIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13514 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027835921 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Required Intervention| D