BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25330768 · Received May 29, 2026

    Report

    Report Number
    1220648-2026-08262
    Event Type
    Injury
    Date Received
    May 29, 2026
    Date of Event
    May 22, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT-DEVICE INTERACTION/THROMBOCYTOPENIA/RENAL FAILURE: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    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

    IMPELLA RP FLEX DEVICE WAS INSERTED VIA THE RIGHT FEMORAL VEIN IN A 37 YEAR-OLD MALE PATIENT PRESENTING WITH ACUTE DECOMPENSATED CARDIOMYOPATHY. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) SHOCK STAGE E. THE PATIENT WAS SUPPORTED WITH BIVENTRICULAR MECHANICAL CIRCULATORY SUPPORT CONSISTING OF IMPELLA CP AND IMPELLA RP FLEX. THE PLATELET COUNT WAS NOTED TO BE 110, DECREASED FROM 239 PRIOR TO IMPELLA INITIATION. THERE WERE NO SUCTION ALARMS REPORTED ON EITHER THE IMPELLA CP OR IMPELLA RP FLEX DEVICES. DURING SUPPORT, THE IMPELLA RP FLEX WAS OPERATING AT PERFORMANCE LEVEL P-4 WITH EXPECTED FLOWS OF 1.7 LITERS PER MINUTE. THE PURGE SOLUTION CONSISTED OF DEXTROSE 5% IN WATER WITH 25 MEQ/L SODIUM BICARBONATE. CENTRAL VENOUS PRESSURE WAS REPORTED AT 16 MILLIMETERS OF MERCURY. WAVEFORMS AND FLOW PARAMETERS ON BOTH DEVICES WERE WITHIN EXPECTED RANGES. NO PLASMA FREE HEMOGLOBIN OR LACTATE DEHYDROGENASE VALUES WERE REPORTED. URINE COLOR WAS DOCUMENTED AS CLEAR YELLOW. THE PATIENT WAS ALSO RECEIVING CONTINUOUS RENAL REPLACEMENT THERAPY. ADDITIONAL CONTRIBUTING FACTORS INCLUDED CONTINUOUS RENAL REPLACEMENT THERAPY AND A REPORTED HISTORY OF DEEP VEIN THROMBOSIS. THE PATIENT WAS SUPPORTED FOR 3 DAYS AND SURVIVED TO EXPLANT. IN PATIENTS SUPPORTED WITH MULTIPLE MECHANICAL CIRCULATORY SUPPORT DEVICES, THERE IS A KNOWN RISK FOR HEMOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22259 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027843967 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1