BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24764859 · Received April 2, 2026

    Report

    Report Number
    1220648-2026-06287
    Event Type
    Injury
    Date Received
    April 2, 2026
    Date of Event
    May 22, 2024
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502011609
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A4 IS UNKNOWN. 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

    CORRECTED INFORMATION WAS PROVIDED IN D3 (MANUFACTURER FAX). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY OMITTED FROM THE INITIAL REPORT. H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    A 12 YEAR OLD FEMALE PATIENT WITH A HISTORY OF CARDIOMYOPATHY AND A PRE SUPPORT CLINICAL STATUS CONSISTENT WITH SCAI SHOCK STAGE C WAS HOSPITALIZED ON (B)(6) 2024 WITH CIRCULATORY FAILURE SECONDARY TO ACUTE MYOCARDITIS. ON HOSPITAL DAY 9, THE PATIENT DEVELOPED LOW GRADE FEVER (37°C). MULTIPLE CULTURES WERE OBTAINED AND WERE UNREMARKABLE, AND EMPIRIC ANTIBIOTIC THERAPY DID NOT RESULT IN CLINICAL IMPROVEMENT. VA ECMO AND TRANSVENOUS PACING WERE DISCONTINUED ON HOSPITAL DAY 10. WHILE THE PATIENT¿S BODY TEMPERATURE WAS INITIALLY CONTROLLED THROUGH CHD CIRCUIT TEMPERATURE MANAGEMENT, DISCONTINUATION OF CHD ON HOSPITAL DAY 14 WAS FOLLOWED BY A RAPID TEMPERATURE INCREASE TO 40°C, ASSOCIATED WITH WORSENING CARDIAC FUNCTION. ANTIPYRETIC THERAPIES, INCLUDING ACETAMINOPHEN AND FLURBIPROFEN AXETIL, WERE INEFFECTIVE, AND CHD WAS RESUMED ON HOSPITAL DAY 15 FOR TEMPERATURE CONTROL. FOLLOWING EXPLANT OF THE IMPELLA CP ON (B)(6) 2024 AT 5:04 AM, THE PATIENT¿S FEVER PATTERN IMPROVED. BASED ON THE AVAILABLE INFORMATION, THIS COMPLAINT DOCUMENTS A FEBRILE EVENT OCCURRING DURING IMPELLA CP SUPPORT IN A PEDIATRIC PATIENT WITH ACUTE MYOCARDITIS AND MULTISYSTEM CRITICAL ILLNESS. EXTENSIVE INFECTIOUS WORKUP DID NOT REVEAL A DEFINITIVE SOURCE, AND THE TEMPORAL IMPROVEMENT IN FEVER FOLLOWING DEVICE EXPLANT WAS NOTED; HOWEVER, THE CONTRIBUTION OF MULTIPLE CONFOUNDING FACTORS¿INCLUDING UNDERLYING MYOCARDITIS, PRIOR VA ECMO, AND CHD¿PRECLUDES DETERMINATION OF A CLEAR CAUSAL RELATIONSHIP BETWEEN THE IMPELLA DEVICE AND THE FEVER. NO DEVICE FAILURE OR MALFUNCTION WAS IDENTIFIED, AND PATIENT OUTCOME WAS SURVIVAL WITH SUCCESSFUL WEANING. THE RELATIONSHIP BETWEEN THE PATIENT¿S FEVER AND THE IMPELLA DEVICE REMAINS NOT CLEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608857 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2024350516 00813502011609

    Patients

    Seq Age Sex Outcome Treatment
    1