BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24778752 · Received April 3, 2026

    Report

    Report Number
    1220648-2026-06372
    Event Type
    Injury
    Date Received
    April 3, 2026
    Date of Event
    March 27, 2026
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. THE CAUSE OF THE HEMOLYSIS ISSUE COULD NOT BE DETERMINED WITHOUT THE RETURNED PRODUCT FOR INVESTIGATION AND SUFFICIENT CLINICAL DETAILS, INCLUDING DATA LOGS.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS SUBSEQUENTLY RECEIVED AND NOTED THE HEMOLYSIS RESOLVED AND THE PATIENT REMAINS ON SUPPORT (AT THE TIME OF THIS MDR WRITING). 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

    EXPLANT DATE WAS PROVIDED D6B WAS UPDATED.

    Additional Manufacturer Narrative · 0

    B5 UPDATED WITH ADDITIONAL INFORMATION

    Additional Manufacturer Narrative · 0

    THE PUMP WAS DISCARDED AND NOT AVAILABLE FOR INVESTIGATION D4 REVISED

    Description of Event or Problem · 0

    AN IMPELLA 5.5 DEVICE WAS INSERTED SURGICALLY INTO THE RIGHT AXILLARY/SUBCLAVIAN ARTERY IN A 65-YEAR-OLD MALE PATIENT WITH A PAST MEDICAL HISTORY OF RENAL INSUFFICIENCY, PRESENTING IN SCAI STAGE C SHOCK, AND ON AN INTRA-AORTIC BALLOON PUMP (IABP), PRIOR TO INITIATION OF SUPPORT. THE IMPELLA WAS INSERTED FOR VENTRICULAR SUPPORT POST-OPERATIVELY CARDIOTHORACIC (CT) SURGERY. WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), THE URINE WAS RED. THE LACTATE DEHYDROGENASE (LDH) IS IN THE 600'S. THE MEAN ARTERIAL PRESSURES WERE 90-100. P-LEVEL DECREASED TO P-6. A NITROGLYCERINE DRIP CONTINUED. THE FOLLOWING MORNING, THE LDH DECREASED AND THE URINE CLEARED. THE POST-PROCEDURE OUTCOME IS UNKNOWN. THE IMPELLA FUNCTIONED AT P-7 AT 4.2L/MIN AS INTENDED. HEMOLYSIS MAY BE INFLUENCED BY PATIENT-SPECIFIC FACTORS SUCH AS CRITICAL ILLNESS, UNDERLYING CARDIAC DYSFUNCTION, HEMODYNAMIC INSTABILITY, AND POTENTIAL DEVICE POSITION

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HEMOLYSIS RESOLVED PRETTY QUICKLY WITH DECREASE IN P LEVEL AND VOLUME ADMINISTRATION. PATIENT REMAINED ON SUPPORT UNTIL (B)(6) , WEANED SUCCESSFULLY AND REMOVED WITH NO ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261141 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. 2026783671 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1