BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5 WITH SMARTASSIST S2 SET, US

    MDR report key: 24474447 · Received February 27, 2026

    Report

    Report Number
    1220648-2026-04259
    Event Type
    Injury
    Date Received
    February 27, 2026
    Date of Event
    December 20, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    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

    ADDITIONAL INFORMATION HAS BEEN PROVIDED IN B5 (EVENT DESCRIPTION), INCLUDING FURTHER DETAIL REGARDING SEQUENCE OF EVENTS AND CLINICAL COURSE. ADDITIONAL INFORMATION HAS BEEN PROVIDED IN B6. ADDITIONAL CODES WERE ADDED IN H6 (HEALTH EFFECT - CLINICAL CODE). 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

    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

    ANEMIA/THROMBOCYTOPENIA: THE ROOT CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    THE CARE TEAM PERFORMED X-RAY AND CT SCAN AND FOUND THE PATIENT TO HAVE A LARGE HEMOTHORAX. A CHEST TUBE WAS PLACED AND >1000ML OF BLOOD WAS DRAINED. THE DEVICE IS NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 0

    A FIFTY-SEVEN-YEAR-OLD MALE PATIENT WITH A MEDICAL HISTORY OF CORONARY ARTERY DISEASE RECEIVED AN IMPELLA 5.5 DEVICE FOR POST-CARDIOTOMY CARDIOGENIC SHOCK FOLLOWING CORONARY ARTERY BYPASS SURGERY. PRIOR TO DEVICE PLACEMENT, THE PATIENT WAS RECEIVING THREE INTRAVENOUS MEDICATIONS TO SUPPORT HEART MUSCLE CONTRACTION AND MECHANICAL VENTILATION, CONSISTENT WITH SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS CARDIOGENIC SHOCK STAGE E. THE PATIENT SHOWED GRADUAL HEMODYNAMIC IMPROVEMENT OVER THE NEXT SEVERAL DAYS. ON THE THIRD DAY OF SUPPORT, THE PATIENT RECEIVED PACKED RED BLOOD CELLS FOR A HEMOGLOBIN LEVEL OF APPROXIMATELY EIGHT GRAMS PER DECILITER; THERE WERE NO SIGNS OF EXTERNAL HEMOLYSIS, AND THE PATIENT WAS NOT RECEIVING HEPARIN OR OTHER ANTICOAGULATION, SO THE LOW HEMOGLOBIN WAS BELIEVED TO BE RELATED TO SURGERY. ON THE FIFTH DAY, THE SURGEON NOTED A DECREASE IN PLATELET COUNT, WITH TESTING NEGATIVE FOR HEPARIN-INDUCED THROMBOCYTOPENIA. THE CAUSE OF THROMBOCYTOPENIA IS UNKNOWN AND LIKELY UNRELATED TO IMPELLA. LATER THAT SAME DAY, THE IMPELLA 5.5 DEVICE WAS REMOVED DUE TO RECOVERY OF NATIVE CARDIAC FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606969 IMPELLA 5.5 WITH SMARTASSIST S2 SET, US TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026690954 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1