BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 25179534 · Received May 14, 2026

    Report

    Report Number
    1220648-2026-07861
    Event Type
    Death
    Date Received
    May 14, 2026
    Date of Event
    May 2, 2026
    Report Date
    May 11, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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. THE ROOT CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    AN IMPELLA CP WAS INSERTED VIA THE LEFT SUBCLAVIAN ARTERY IN A 53-YEAR-OLD MALE PATIENT PRESENTING IN SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) STAGE D CARDIOGENIC SHOCK, WITH THE INITIAL INDICATION LISTED AS PREOPERATIVE PLACEMENT. THE PATIENT HAD BEEN ON IMPELLA SUPPORT SINCE ON (B)(6), REQUIRING FOUR ADDITIONAL IMPELLA PUMPS DURING THE COURSE OF THERAPY. DURING ONGOING SUPPORT, SYSTEMIC HEPARIN WAS HELD DUE TO THE PATIENT DEVELOPING A BRAIN BLEED, WHICH WAS CONFIRMED ON IMAGING. THE PATIENT WAS UNDERGOING FREQUENT NEUROLOGIC ASSESSMENTS EVERY 15 MINUTES FOR STROKE MONITORING. GIVEN THE SEVERITY OF THE PATIENT¿S OVERALL CLINICAL CONDITION, A DECISION WAS LATER MADE TO WITHDRAW CARE, AND THE PATIENT EXPIRED. THE DEATH IS CONSERVATIVELY REPORTED; HOWEVER, THE PATIENT¿S OUTCOME IS MOST CONSISTENT WITH REFRACTORY CARDIOGENIC SHOCK AND PROGRESSION OF UNDERLYING CRITICAL ILLNESS PRESENT PRIOR TO AND DURING IMPELLA SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192975 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027868348 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1