BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25068033 · Received May 4, 2026

    Report

    Report Number
    1220648-2026-07387
    Event Type
    Injury
    Date Received
    May 4, 2026
    Date of Event
    April 26, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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

    B5 UPDATED WITH ADDITIONAL INFORMATION. A COMPLAINT FOR THE CONSOLE HAS BEE CREATED AND MFR IS PENDING.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE:AN IMPELLA 5.5 WAS INSERTED VIA THE AXILLARY ARTERY GRAFT SITE TO SUPPORT THE 62 YEAR OLD MALE PATIENT ADMITTED IN WITH CARDIOMYOPATHY, PRESENTING IN SCAI STAGE E SHOCK. THE UNDERLYING MEDICAL HISTORY WAS NOT SHARED.THE PUMP WAS SUPPORTING WHEN ON DAY 17 THERE WAS AN OBSERVATION MADE OF PURGE FLOW DROPPING TO 2.6ML/HR AND PURGE PRESSURE AT 900S. THE TEAM MADE DECISION TO TROUBLESHOOT BY ADDING THE LYTIC, TPA, TO THE PURGE. AFTER A FEW HOURS THE PURGE FLOW RETURNED TO BASELINE AND PURGE WAS CHANGED BACK TO DEXTROSE AND SODIUM BICARBONATE. NO PURGE ALARMS WERE PRESENT ANY LONGER.THE PUMP REMAINS ON FOR SUPPORT, WELL BEYOND THE PUMP INDICATION USE AS CURRENTLY ON DAY 22.TPA WAS UTILIZED FOR THE PURGE ALARMING TO MITIGATE IMPACT OF BIOMATERIAL WITHIN THE MOTOR AND THERE WAS NO IMPACT ON THE PATIENT.

    Description of Event or Problem · 0

    US CLINICAL NARRATIVE: (UPDATED 2026-5-6). AN IMPELLA 5.5 WAS INSERTED VIA THE AXILLARY ARTERY GRAFT SITE TO SUPPORT THE 62 YEAR OLD MALE PATIENT ADMITTED IN WITH CARDIOMYOPATHY, PRESENTING IN SCAI STAGE E SHOCK. THE UNDERLYING MEDICAL HISTORY WAS NOT SHARED. THE PUMP WAS SUPPORTING WHEN ON DAY 17 THERE WAS AN OBSERVATION MADE OF PURGE FLOW DROPPING TO 2.6ML/HR AND PURGE PRESSURE AT 900S. THE TEAM MADE DECISION TO TROUBLESHOOT BY ADDING THE LYTIC, TPA, TO THE PURGE. AFTER A FEW HOURS THE PURGE FLOW RETURNED TO BASELINE AND PURGE WAS CHANGED BACK TO DEXTROSE AND SODIUM BICARBONATE. NO PURGE ALARMS WERE PRESENT ANY LONGER. THE PUMP REMAINS ON FOR SUPPORT, WELL BEYOND THE PUMP INDICATION USE AS CURRENTLY ON DAY 22. TPA WAS UTILIZED FOR THE PURGE ALARMING TO MITIGATE IMPACT OF BIOMATERIAL WITHIN THE MOTOR AND THERE WAS NO IMPACT ON THE PATIENT. THE TEAM ALSO FOUND THERE WAS A MALFUNCTION ASSOCIATED WITH THE AUTOMATED IMPELLA CONTROLLER (AIC). THE CONSOLE WAS NOT CHARGING, TO TROUBLESHOOT THE TEAM SWITCHED THE OUTLET, BUT WHEN THIS DID NOT RESOLVE THE ISSUE THE AIC WAS SWAPPED OUT WITH A NEW CONSOLE. THIS WAS FOUND ON DAY 27. THE PUMP AND AIC REMAIN ON FOR SUPPORT TO DATE WITHOUT HARM FROM THE EXCHANGE. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54286 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027822621 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1