BEUDAMED
    FDA Adverse Event Death Summary report: N

    TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

    MDR report key: 24871711 · Received April 14, 2026

    Report

    Report Number
    1220648-2026-06722
    Event Type
    Death
    Date Received
    April 14, 2026
    Date of Event
    April 7, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502013948
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO THE PATIENT'S DEATH, THE PUMP AND SHEATH WERE REMOVED SIMULTANEOUSLY. SINCE THEY WERE NOT REMOVED SEPARATELY, THE PUMP WAS NOT REMOVED THROUGH THE SHEATH. THE DEVICE WAS DISCARDED. 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 CPC10 DEVICE WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN A MALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS). THE PATIENT¿S COMORBIDITIES AND CLINICAL STATE PRIOR TO SUPPORT WERE UNKNOWN. DURING SUPPORT, A THROMBUS WAS DISCOVERED LODGED IN THE PUMP DISCHARGE SECTION. THE THROMBUS WAS IDENTIFIED IN THE PUMP AFTER THE PATIENT DIED. SUBSEQUENT COMMUNICATION WITH THE TREATING PHYSICIAN REVEALED THAT THE MAIN CAUSE OF DEATH WAS SUBARACHNOID HEMORRHAGE (SAH). IT WAS UNCLEAR WHETHER THE IMPELLA DEVICE WAS INVOLVED. THE PUMP HAD BEEN SCHEDULED FOR REMOVAL, BUT THE PATIENT DIED PRIOR TO THE PLANNED EXPLANT. THE PHYSICIAN NOTED THAT EVEN IF IMPELLA FLOW COULD NOT BE OBTAINED DUE TO THE THROMBUS, IT WAS UNLIKELY THAT CIRCULATORY DEATH WOULD HAVE OCCURRED SOLELY AS A RESULT. THE PATIENT EXPIRED ON SUPPORT. THE THROMBOSIS MAY BE ASSOCIATED WITH PATIENT-SPECIFIC FACTORS SUCH AS UNDERLYING CARDIOGENIC SHOCK, CRITICAL ILLNESS AND ANTICOAGULATION STATUS. THE STROKE MAY BE RELATED TO THE PATIENT'S UNDERLYING CRITICAL ILLNESS AND OTHER CLINICAL FACTORS, WITH NO CLEAR EVIDENCE OF DIRECT DEVICE INVOLVEMENT. THE DEVICE WILL BE CONSERVATIVELY REPORTED FOR DEATH; HOWEVER, THE DEATH IS MOST LIKELY ATTRIBUTED TO THE PATIENT¿S UNDERLYING CRITICAL CLINICAL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371028 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026810904 00813502013948

    Patients

    Seq Age Sex Outcome Treatment
    1