BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 25172231 · Received May 14, 2026

    Report

    Report Number
    1220648-2026-07824
    Event Type
    Death
    Date Received
    May 14, 2026
    Date of Event
    May 7, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2 AND A4 ARE UNKNOWN. THE EXACT DATE OF DEATH IS UNKNOWN BUT HAS BEEN CAPTURED AS THE DATE OF EXPLANT. IF ADDITIONAL INFORMATION BECOMES KNOWN, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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

    UPDATED INFORMATION: D3 MFR FAX NUMBER ADDED. H6 MED DEV PROB CODE REMOVED A150202. H6 IMPACT CODE REMOVED F1904.

    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 CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    AN IMPELLA CP DEVICE WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN A 67-YEAR-OLD MALE PATIENT PRESENTING WITH HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION (HRPCI). THE PATIENT HAD A HISTORY OF DIABETES MELLITUS. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS IDENTIFIED AS SCAI SHOCK STAGE E. DURING SUPPORT, RED URINE WAS NOTED IN THE FOLEY BAG. ECHOCARDIOGRAPHY SHOWED THE OUTLET AT THE VALVE, AND THE PUMP WAS PULLED BACK, RESULTING IN CLEARING OF THE URINE. DESPITE THESE INTERVENTIONS, THE PATIENT¿S HEMODYNAMIC INSTABILITY PROGRESSED, AND THE CLINICAL TEAM DECIDED TO UPGRADE SUPPORT TO AN IMPELLA 5.5 DEVICE. ULTIMATELY, CARE WAS SUBSEQUENTLY WITHDRAWN, AND THE PATIENT EXPIRED. HEMATURIA MAY OCCUR IN THE SETTING OF PURGE-RELATED ANTICOAGULATION REQUIREMENTS AND MAY BE INFLUENCED BY DEVICE POSITION. THE DEVICE WILL BE CONSERVATIVELY REPORTED FOR DEATH; HOWEVER, THE DEATH IS MOST LIKELY ATTRIBUTED TO THE PATIENT¿S UNDERLYING CRITICAL CLINICAL CONDITION AS THEY PRESENTED IN SCAI SHOCK STAGE E.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378818 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026805427 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1