BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24443323 · Received February 25, 2026

    Report

    Report Number
    1220648-2026-03997
    Event Type
    Death
    Date Received
    February 25, 2026
    Date of Event
    February 17, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED; THEREFORE, EVALUATION AND ANALYSIS COULD NOT BE PERFORMED. A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND CONFIRMED THE PUMP PASSED ALL POST STERILE INSPECTION CHECKS. THE CAUSE(S) OF THE REPORTED HEMATOMA (ACCESS SITE ADVERSE EVENT) COULD NOT BE DETERMINED DUE TO INSUFFICIENT CLINICAL INFORMATION. H6 COMPONENT CODING AND INVESTIGATION TYPE, FINDINGS AND CONCLUSION CODING HAVE BEEN UPDATED BASED ON THE COMPLETED INVESTIGATION. CORRECTION. D1 BRAND NAME WAS CORRECTED ACCORDINGLY.

    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.

    Description of Event or Problem · 0

    CLINICAL RATIONALE: AN IMPELLA CP WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN AN 81-YEAR-OLD MALE PATIENT WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK (AMI/CGS) WHO PRESENTED IN SCAI STAGED SHOCK. DURING THE CASE, THE CLINICAL TEAM REPORTED THAT THE PATIENT RECEIVED ONE UNIT OF BLOOD IN THE CATH LAB AND THAT A SMALL HEMATOMA WAS PRESENT AT THE ACCESS SITE. NO ALLEGATIONS OF IMPELLA MALFUNCTION WERE MADE, AND NO DEVICE RELATED CONCERNS WERE DOCUMENTED. THE DEVICE WAS NOT REMOVED DUE TO THE HEMATOMA. THE PATIENT REMAINED PROFOUNDLY ILL AND ULTIMATELY EXPIRED DESPITE ONGOING CRITICAL CARE SUPPORT. BASED ON THE AVAILABLE INFORMATION, THE PATIENT¿S DEATH APPEARS CLINICALLY ATTRIBUTABLE TO THE SEVERITY OF UNDERLYING AMI/CGS AND CARDIOGENIC SHOCK, RATHER THAN TO ANY MALFUNCTION OR PERFORMANCE ISSUE OF THE IMPELLA CP. THE SMALL ACCESS SITE HEMATOMA IS CONSISTENT WITH KNOWN VASCULAR ACCESS RISKS AND SHOWS NO EVIDENCE OF DEVICE CAUSALITY. THE DEATH IS CONSERVATIVELY BEING REPORTED ON THE IMPELLA CP BUT IS UNLIKELY A CONTRIBUTING FACTOR TO THE CAUSE OF DEATH AND IS MORE LIKELY DUE TO THE PATIENT¿S DECLINING CLINICAL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510923 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027828825 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Death