BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24518489 · Received March 5, 2026

    Report

    Report Number
    1220648-2026-04512
    Event Type
    Death
    Date Received
    March 5, 2026
    Date of Event
    February 16, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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.

    Additional Manufacturer Narrative · 0

    DEVICE MANUFACTURE DATE WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION HAS BEEN PROVIDED IN D1 BRAND NAME. H6 INVESTIGATION: TYPE, FINDINGS, AND CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    CLINICAL RATIONALE: AN IMPELLA CP DEVICE WAS INSERTED INTO THE RIGHT FEMORAL ARTERY IN A 80-YEAR-OLD MALE PATIENT WITH A PAST MEDICAL HISTORY OF A PRIOR CORONARY ARTERY BYPASS GRAFT (CABG), AND CORONARY ARTERY DISEASE (CAD), PRESENTING IN SCAI STAGE A SHOCK, PRIOR TO INITIATION OF SUPPORT. THE IMPELLA WAS INSERTED FOR VENTRICULAR SUPPORT FOR A HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING THE PCI OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD), THE PATIENT DROPPED PULSATILITY, AND THEN BEGAN LOSING PRESSURES. DOPAMINE AND LEVOPHED WERE STARTED. THE PATIENT CODED AND WAS INTUBATED FOR RESPIRATORY SUPPORT. A PERICARDIAL EFFUSION WAS NOTED ON ECHOCARDIOGRAM AND A DRAINAGE WAS PLACED. A POSSIBLE DISSECTION OF THE LAD WAS NOTED. THE PATIENT CONTINUED TO CODE, AND EXPIRED ON SUPPORT IN THE PROCEDURE AREA. THE DEVICE IS UNLIKELY TO HAVE CONTRIBUTED TO THE PATIENT'S DEATH, WHICH WAS MOST LIKELY DUE TO THE DISSECTION IN THE LAD CAUSING THE PERICARDIAL EFFUSION. LAD DISSECTION CAN LEAD TO CARDIAC ARREST OR DEATH DUE TO THE ROLE THE LAD PLAYS IN SUPPLYING BLOOD TO A LARGE PORTION OF THE HEART MUSCLE. IT NOT TREATED INSTANTLY, THE DAMAGE CAN BE FATAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402292 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027823506 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1