BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25276722 · Received May 26, 2026

    Report

    Report Number
    1220648-2026-08149
    Event Type
    Injury
    Date Received
    May 26, 2026
    Date of Event
    May 18, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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.

    Description of Event or Problem · 0

    AN IMPELLA CP DEVICE WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN AN 80-YEAR-OLD FEMALE PATIENT FOR PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PCI) IN THE SETTING OF SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) STAGE A SHOCK. THE PATIENT¿S COMORBIDITIES WERE NOT REPORTED. DURING IMPELLA CP SUPPORT, THE PATIENT WAS NOTED TO HAVE RED URINE OUTPUT. URINALYSIS WAS OBTAINED, AND FINDINGS WERE DESCRIBED AS FRANK BLOOD WITH SUSPECTED BLOOD CLOTS, AS URINE OUTPUT IMPROVED FOLLOWING IRRIGATION. CREATININE AND URINE OUTPUT REMAINED WITHIN ACCEPTABLE LIMITS, INDICATING PRESERVED RENAL FUNCTION. THE IMPELLA PURGE SOLUTION CONSISTED OF DEXTROSE 5 PERCENT IN WATER WITH 25 MILLIEQUIVALENTS OF SODIUM BICARBONATE. THE DEVICE WAS FUNCTIONING AT PERFORMANCE LEVEL P-6 WITH A FLOW OF APPROXIMATELY 3.0 LITERS PER MINUTE. THE REPORTED HEMATURIA IS CONSISTENT WITH KNOWN CLINICAL CONSIDERATIONS DURING IMPELLA CP SUPPORT, INCLUDING ANTICOAGULATION THERAPY, URINARY CATHETERIZATION, AND PATIENT-SPECIFIC HEMODYNAMIC CONDITIONS. THE PATIENT SURVIVED TO EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500554 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026757823 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1