BEUDAMED
    FDA Adverse Event Death Summary report: N

    TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

    MDR report key: 24843610 · Received April 10, 2026

    Report

    Report Number
    1220648-2026-06595
    Event Type
    Death
    Date Received
    April 10, 2026
    Date of Event
    April 3, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502013344
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. 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.

    Additional Manufacturer Narrative · 0

    B5 UPDATED WITH ADDITIONAL INFORMATION RECEIVED FROM THE CLINICAL SITE.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY TO SUPPORT THE 42-YEAR-OLD FEMALE PATIENT WHO HAD BEEN ADMITTED IN WITH INDICATION OF ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE E SHOCK. PRIOR TO HOSPITAL ADMISSION THE PATIENT WAS KNOWN TO HAVE AN OUT OF HOSPITAL CARDIAC ARREST AND CPR GIVEN. IN HOSPITAL BEFORE THE CP WAS INSERTED THE PATIENT WAS ON INOTROPES, VASOPRESSORS, AND A VENT FOR RESPIRATORY NEEDS. OTHER UNDERLYING MEDICAL HISTORY WAS NOT SHARED, BEYOND PERIPHERAL ARTERIAL DISEASE. ON THE DAY OF CP IMPLANT THERE WAS LIMB ISCHEMIA, THE LEG HAD PALLOR/COLOR CHANGE, THAT PROMPTED THE MEDICAL TEAM TO UTILIZE FEM-FEM BYPASS TO PERFUSE THE CP ACCESSED LIMB. THERE WAS KNOWN HIGH DOSE VASOPRESSIN THAT COULD HAVE DECREASED THE FLOW SIGNIFICANTLY. THE LEG BEGAN TO IMPROVE BUT WORSENED LATER. THE PATIENT DID EXPIRE AFTER 3 DAYS OF SUPPORT. THE CAUSE OF DEATH WAS NOTED TO BE DISTRIBUTIVE SHOCK/SEPSIS AND VENTRICULAR ARRYTHMIA. THE DEATH IS CONSERVATIVELY BEING REPORTED ALTHOUGH AN UNLIKELY CONTRIBUTING FACTOR TO THE DEATH, AND MORE LIKELY THE PATIENT'S PRESENTING NATIVE CRITICAL CONDITION AS PRESENTED IN SCAI STAGE E. ISCHEMIA MAY BE INFLUENCED BY PATIENT-SPECIFIC FACTORS SUCH AS SEVERE PERIPHERAL VASCULAR DISEASE, UNDERLYING CRITICAL ILLNESS, HEMODYNAMIC INSTABILITY, AND VASCULAR ACCESS CHARACTERISTICS.

    Description of Event or Problem · 0

    THE VENTRICULAR ARRYTHMIA WAS PRESENT BEFORE IMPLANTATION OF THE IMPELLA CP. THE PATIENT WAS TREATED WITH IMPELLA AND A TEMPORARY PACEMAKER. THE PUMP WAS EXPLANTED IN ANOTHER HOSPITAL AND IS NOT AVAILABLE ANYMORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372227 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026806649 00813502013344

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Unknown Required Intervention| D