BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA

    MDR report key: 24601596 · Received March 15, 2026

    Report

    Report Number
    1220648-2026-05281
    Event Type
    Malfunction
    Date Received
    March 15, 2026
    Date of Event
    November 13, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502010022
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    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

    D6A AND D6B SHOULD HAVE BEEN LEFT BLANK. THE IMPELLA DEVICE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON COMPLETION OF OUR ANALYSIS, A SUPPLEMENTAL REPORT WILL BE FILED. D9 UPDATED.

    Description of Event or Problem · 0

    25 YEAR OLD MALE PATIENT TREATED WITH IMPELLA 5.5 DUE TO HEART FAILURE COMPLICATED BY CARDIOGENIC SHOCK REDUCED EJECTION FRACTION OF 10 % NOTED. PATIENT ADMITTED TO HOSPITAL BECAUSE OF SHORTNESS OF BREATH AND HYPOTENSION. PATIENT HAS LIMITED PAST MEDICAL HISTORY, BUT IS ABUSING ALCOHOL DAILY. PATIENT BECAME HYPOXIC AND TACHYPNEIC REQUIRING INTUBATION AND WAS CANNULATED FOR EXTRACORPOREAL LIFE SUPPORT. PATIENT TAKEN TO OPERATING ROOM FOR EXCTRACORPOREAL LIFE SUPPORT DECANNULATION AND IMPELLA 5.5. INSERTION. IMPELLA PLACED WITHOUT ISSUES AND POSITION MEASURED BY ECHO AS OPTIMAL. DAY THREE OF SUPPORT SOME OOZING PRESENT AT RIGHT AXILLARY INSERTION SITE AND PINK TO RED URINE OUTPUT. NO FURTHER EVALUATION MADE, THEREFORE CONSERVATIVELY CODED TO HEMATURIA AND SERIOUS INJURY. DAY FIVE OF SUPPORT HEMATOMA FORMED AND PAIN AS WELL AS ACCESS SITE CONTINUED TO GET WORSE - NEW DRAIN WAS INITIATED TO RELIEVE. PATIENT HAD ORTHOSTATIC HYPOTENSION EPISODE AND RECOVERED WHEN RESTED - CODED FOR HEMODYNAMIC INSTABILITY. 2.5 WEEKS AFTER INITIATION OF SUPPORT AUTOMATED IMPELLA CONTROLLER ALARMS OF CONTROLLER FAILURE AND INTERMITTED LOSS OF AORTIC AND VENTRICULAR PLACEMENT METRICS - SELF RESOLVING, BUT TEAM WAS PREPARED FOR A CONTROLLER SWITCH IF NEEDED. PATIENT SUCCESSFULLY WEANED AFTER ALMOST FOUR WEEKS OF SUPPORT, WHICH IS BEYOND THE RECOMMENDED TIME OF SUPPORT. 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. ON DAY 23 OF IMPELLA 5.5 SUPPORT, THE AUTOMATED IMPELLA CONTROLLER (AIC) HAD ISSUES WITH INTERMITTENT CONTROLLER FAILURE ALARMS. THIS COINCIDE WITH INTERMITTENT LOSS OF AORTIC AND LEFT VENTRICLE PRESSURE MEASUREMENTS, AS EXPECTED DURING A CONTROLLER FAILURE ALARM. THE ALARMS WERE SELF-RESOLVING. THE DECISION WAS MADE TO KEEP THE CURRENT AIC AS EXPLANT WAS PLANNED FOR THE COMING DAYS, BUT TEAM IS PREPARED TO REPLACE THE AIC IF IT FAILS. THERE IS NO FURTHER MENTION OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92778 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 1095647 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1