BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24728221 · Received March 30, 2026

    Report

    Report Number
    1220648-2026-06101
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    March 22, 2026
    Report Date
    April 13, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL ONGOING.

    Additional Manufacturer Narrative · 0

    UPON REVIEW, IT WAS IDENTIFIED THAT THE PRODUCT PROBLEM (B1) WAS INADVERTENTLY OMITTED IN ERROR FROM INITIAL AND HAS NOW BEEN PROVIDED. UPON REVIEW, IT WAS IDENTIFIED THAT THE MANUFACTURER FAX (D3) WAS INADVERTENTLY OMITTED IN ERROR; THE COMPLETE FAX NUMBER HAS NOW BEEN PROVIDED. CORRECTED INFORMATION HAS BEEN PROVIDED IN D4 SERIAL NUMBER. H6 INVESTIGATION: TYPE, FINDINGS, AND CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE CAUSE OF HEMOLYSIS WAS NOT DETERMINED DUE TO LACK OF CLINICAL DETAILS, NO PRODUCT OR DATA LOGS RETURNED FOR ANALYSIS. THE CAUSE OF POSITION ISSUE WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS AND NO PRODUCT WAS RETURNED.

    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

    THE COMPLAINANT REPORTED THE DEVICE HAS BEEN DISPOSED OF AND WILL NOT BE AVAILABLE FOR RETURN.

    Description of Event or Problem · 0

    AN IMPELLA CP WAS INSERTED VIA RIGHT FEMORAL ARTERY IN A 23 YEAR OLD MALE FOR ACUTE MYOCARDIAL INFARCTION WITH CARDIOGENIC SHOCK. THE PATIENT¿S COMORBIDITIES WERE UNKNOWN. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS SCAI STAGE D. ON DAY 3 OF SUPPORT, THE PATIENT'S URINE WAS TINGED PINK AND CONTINUED TO DARKEN. LABS HEMOLYZED AND THERE WERE INTERMITTENT PLACEMENT SIGNAL LOW ALARMS ON THE AUTOMATED IMPELLA CONTROLLER. ECHOCARDIOGRAM SHOWED THE PUMP WAS DEEP, AND MEASURED APPROXIMATELY 6CM INTO THE LEFT VENTRICLE. IT WAS REPORTED THE PHYSICIAN WOULD REPOSITION THE DEVICE. ON DAY 5 OF SUPPORT, THE PATIENT WAS SUCCESSFULLY BRIDGED TO IMPELLA 5.5. THE REPORTED HEMOLYSIS MAY OCCUR IN THE SETTING OF PURGE-RELATED ANTICOAGULATION REQUIREMENTS AND MAY BE INFLUENCED BY PATIENT-SPECIFIC FACTORS SUCH AS THE UNDERLYING CARDIOGENIC SHOCK PHYSIOLOGY, HEMODYNAMIC INSTABILITY, AND DEVICE POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228463 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026808681 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1