BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA CONTROLLER, PACKAGED, US

    MDR report key: 24530518 · Received March 6, 2026

    Report

    Report Number
    1220648-2026-04605
    Event Type
    Malfunction
    Date Received
    March 6, 2026
    Date of Event
    November 7, 2025
    Report Date
    March 25, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN PROVIDED IN D4 AND H4 (DEVICE EXPIRATION DATE, MANUFACTURING DATE AND UDI). 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

    E4 WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT.

    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.

    Description of Event or Problem · 0

    CLINICAL ASSESSMENT: 63 YEAR OLD MALE PATIENT TREATED WITH IMPELLA 5.5 DUE TO ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK. PATIENT WAS ADMITTED TO HOSPITAL FOR HEART FAILURE. PATIENT ACUTELY IN CARDIOGENIC SHOCK AND HAD CARDIAC ARREST IN CATHETER LABORATORY. PLACED ON EXTRACORPOREAL LIFE SUPPORT AND WHEN PATIENT LOST CONTRACTILITY AND EJECTION FRACTION WAS DEEMED 5 % EMERGENT IMPELLA 5.5 INSERTION DECISION WAS TAKEN. DURING INSERTION SHEATH PLACED AND HCP WAS UNABLE TO GET HEMOSTASIS. SHEATH APPEARS TO BE LEAKING AND DECISION WAS TAKEN TO REPLACE SHEATH WITH A NEW ONE. FIRST DAY OF SUPPORT PUMP EXPERIENCED DROP IN PURGE FLOWS WITHOUT SPIKES IN MOTOR CURRENT. NO FURTHER CHANGES IN OTHER PUMP METRICS AND NO PURGE PRESSURE ALARMS AS WELL AS NO LEAKES IN THE SYSTEM. DECISION WAS TAKEN FOLLWING MD CONSULATION TO EXCHANGE PURGE FOR TISSUE PLASMINOGEN ACTIVATOR. DAY SIX OF SUPPORT PATIENT DECANNULATED FROM EXTRACORPOREAL LIFE SUPPORT AND EXPEREINCED NEUROLOGICAL DELAYS AND POSSIBLE STROKE SYMPTOMS - THIS IS CONSERVATIVELY CODED FOR STROKE IN THIS CASE TO THE IMPLELA 5.5, BUT DUE TO MULTIPLE MECHANICAL CIRTULATORY SUPPORT SYSTEMS CANNOT SOLELY BE ATTIBUTED TO THE IMPELLA SYSTEM. DAY SEVEN OF SUPPORT PATIENT HAD TO BE REINTUBATED DUE TO INCREASED SECRATION. DAY 14 OF SUPPORT THE PLACEMENT SIGNAL AND THE MEASSURED BLOOD PRESSURE WERE NOT CORRSPONDING. FOLLOWING ONE MONTH OF SUPPORT PLATELET DECREASE WAS NOTED AND CODED HERE FOR THROMOCYTOPENIA. RESULT WAS ECHO MESUREMENT AND POSSIBLE REPOSITIONING - AS NO FURTHER INFORMATION AVAILABLE CONSERVATIVELY CODED TO DEVICE REPOSITIONING HERE. PATIENT EXPEREINCED FREQUENT PURGE ALARMS WITH FLOW RANGING FROM 8 TO 11.5 ML/HR AND NO CHANGES IN PURGE PRESSURE. TUBING AND CASSETTE WERE CHECKED. NEXT DAY AFTER MORE ALARMS DECISION MADE TO CHANGE PURGE CASSETTE. AFTER ONE MONTHS AND TWO DAYS OF SUPPORT NOTED PLACEMENT SIGNAL FLICKERING IN AND OUT - NO FURTHER INFORMATION AND CI WAS MENTIONED TO BE PLACED, BUT NOT IN SYSTEM. PATIENT SUCCESSFULLY BRIDGED TO TRANSPLANT AFTER ALMOST TWO MONTHS OF IMPELLA 5.5 SUPPORT, WHICH IS BEYOND THE RECOMMENDATIONS IN THE INSTRUCTIONS FOR USE. THE USE OF MULTIPLE MECHANICAL CIRCULATORY SUPPORT SYSTEMS, SUCH AS COMBINED IMPELLA AND EXTRACORPOREAL CIRCULATORY LIFE SUPPORT (ECLS) THERAPY, IS ASSOCIATED WITH AN INCREASED RISK OF ADVERSE EVENTS DUE TO THE CUMULATIVE COMPLEXITY OF THE SUPPORT STRATEGY AND THE ADDITIVE DEVICE-RELATED RISKS. IMPELLA SUPPORT WAS CONTINUED BEYOND THE RECOMMENDED 14 DAY DURATION; PROLONGED USE CAN INCREASE THE RISK OF COMPLICATIONS AND THEREFORE MAY HAVE PLAYED A CONTRIBUTORY ROLE IN THIS ADVERSE EVENT. ENGINEERING ASSESSMENT: DURING IMPELLA 5.5 SUPPORT, THERE WAS AS ISSUE WITH THE AUTOMATED IMPELLA CONTROLLER'S (AIC) DISPLAY OR VISUAL FEEDBACK. ON APPROXIMATELY DAY 29 OF SUPPORT, THE ABIOMED REPRESENTATIVE DOCUMENTED THAT THE PLACEMENT SIGNAL WAS ""FLICKERING IN AND OUT"" IN THE PATIENT UPDATE NOTES. THERE IS NO FURTHER MENTION OF THIS ISSUE. NOTE FOR BRENDA: THE NOTE (12/9) SAYS A CI WAS PLACED, BUT THERE'S NO CI OR FM CORRESPONDING TO THIS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315730 IMPELLA CONTROLLER, PACKAGED, US TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 IMPELLA CONTROLLER, PACKAGED, US 1139665

    Patients

    Seq Age Sex Outcome Treatment
    1