BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24544438 · Received March 9, 2026

    Report

    Report Number
    1220648-2026-04735
    Event Type
    Injury
    Date Received
    March 9, 2026
    Date of Event
    February 23, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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

    D6B EXPLANT DATE PROVIDED.

    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. CORRECTED INFORMATION HAS BEEN PROVIDED IN D1 THE CAUSE OF THE ISSUE WAS NOT ESTABLISHED AS NO PRODUCT OR LOGS WERE RETURNED AND INSUFFICIENT INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    AN IMPELLA CP WAS INITIALLY INSERTED FOR CIRCULATORY SUPPORT IN A 75-YEAR-OLD FEMALE PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK. PRIOR TO DEVICE INSERTION, THE PATIENT¿S LEFT VENTRICULAR EJECTION FRACTION WAS 30% AND THE STARTING LACTATE WAS 2.2. THE PATIENT REQUIRED INOTROPIC THERAPY, VASOPRESSOR SUPPORT, AND MECHANICAL VENTILATION FOR RESPIRATORY SUPPORT DUE TO HEMODYNAMIC COMPROMISE AND WAS CLASSIFIED AS SCAI STAGE D CARDIOGENIC SHOCK. THE PURGE SOLUTION CONSISTED OF DEXTROSE 5% IN WATER WITH 25 MILLIEQUIVALENTS SODIUM BICARBONATE. CIRCULATORY SUPPORT WAS LATER ESCALATED TO AN IMPELLA 5.5 VIA THE RIGHT AXILLARY ARTERY. DURING SUPPORT, THE PATIENT DEVELOPED RED-COLORED URINE WITH CLINICAL CONCERN FOR HEMOLYSIS, AND THE PATIENT EXPERIENCE INCLUDED HEMOLYSIS ASSOCIATED WITH THE PUMP. DUE TO CONCERN FOR ONGOING HEMOLYSIS AND THE PATIENT¿S HEMODYNAMIC CONDITION, THE CARE TEAM UPGRADED SUPPORT TO AN IMPELLA 5.5 DEVICE TO PROVIDE ENHANCED CIRCULATORY ASSISTANCE. A COMPREHENSIVE REVIEW OF THE AVAILABLE INFORMATION INDICATES THAT HEMOLYSIS IS A RECOGNIZED POTENTIAL COMPLICATION ASSOCIATED WITH TEMPORARY MECHANICAL CIRCULATORY SUPPORT SYSTEMS, PARTICULARLY IN PATIENTS WITH SEVERE CARDIOGENIC SHOCK REQUIRING HIGH LEVELS OF CIRCULATORY SUPPORT. MULTIPLE CLINICAL FACTORS, INCLUDING UNDERLYING MYOCARDIAL INFARCTION, SHOCK PHYSIOLOGY, AND CRITICAL ILLNESS, MAY CONTRIBUTE TO THE DEVELOPMENT OF HEMOLYSIS DURING SUPPORT. THE PATIENT SURVIVED THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29755 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027831537 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1