BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24680447 · Received March 24, 2026

    Report

    Report Number
    1220648-2026-05866
    Event Type
    Injury
    Date Received
    March 24, 2026
    Date of Event
    March 16, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    UNKNOWN IF THE HEMOLYSIS WAS CONFIRMED.

    Additional Manufacturer Narrative · 0

    H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION AND ADDED CLINICAL REVIEW. THE ROOT CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA 5.5 DEVICE WAS INSERTED SURGICALLY INTO THE RIGHT AORTA IN A 70-YEAR-OLD MALE PATIENT WITH A PAST MEDICAL HISTORY OF CORONARY ARTERY DISEASE (CAD), PRESENTING IN SCAI STAGE C SHOCK, ON MULTIPLE INOTROPES AND VASOPRESSORS, PRIOR TO INITIATION OF SUPPORT. THE IMPELLA WAS INSERTED FOR VENTRICULAR SUPPORT FOR A CARDIOTHORACIC (CT) SURGERY: CORONARY ARTERY BYPASS GRAFT (CABG). WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), THERE WAS HEMATURIA. AN ECHOCARDIOGRAM CONFIRMED POSITION AND THE P-LEVEL WAS LOWERED WITH NO IMPROVEMENT. THE PLAN IS TO REMOVE THE PUMP. FOUR DAYS AFTER IMPELLA INSERTION, THE DEVICE WAS SUCCESSFULLY WEANED. THE POST-PROCEDURE OUTCOME IS SURVIVED AT EXPLANT. THE IMPELLA FUNCTIONED AT P-3 AT 2.2L/MIN AS INTENDED. BLEEDING (HEMATURIA) IS A KNOWN RISK DUE TO THE IMPELLA'S ANTICOAGULATION AND PURGE REQUIREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150619 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026813102 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1