BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CONTROLLER, PACKAGED, US

    MDR report key: 24647927 · Received March 20, 2026

    Report

    Report Number
    1220648-2026-05696
    Event Type
    Injury
    Date Received
    March 20, 2026
    Date of Event
    March 12, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502010022
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B1: ADDED PRODUCT PROBLEM, THIS WAS OMITTED FROM THE INITIAL IN ERROR. D9: UPDATED THE DEVICES RETURN INFORMATION.

    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

    AN IMPELLA CP DEVICE WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN AN 82-YEAR-OLD MALE PATIENT PRESENTING FOR HIGH-RISK PCI (HRPCI), SCAI SHOCK STAGE C, WITH A HISTORY OF KNOWN CORONARY ARTERY DISEASE, RENAL INSUFFICIENCY, AND DIALYSIS. DURING HRPCI FOLLOWING SEQUENTIAL INTERVENTIONS TO THE LAD INCLUDING ANGIOPLASTY, SHOCKWAVE THERAPY, AND DEPLOYMENT OF ONE DRUG-ELUTING STENT THE LCX WAS BEING WIRED FOR ATHERECTOMY WHEN THE OPTICAL SENSOR STOPPED FUNCTIONING AND NO WAVEFORM WAS VISIBLE ON THE IMPELLA CONTROLLER. APPROXIMATELY 30 SECONDS LATER, A CONTROLLER-FAILURE ALARM APPEARED ON THE AUTOMATED IMPELLA CONTROLLER (AIC). A SECOND AIC WAS BROUGHT INTO THE ROOM. ALTHOUGH THE INITIAL ALARM TEMPORARILY RESOLVED, THE PHYSICIAN ELECTED TO TRANSITION THE IMPELLA TO THE NEW CONSOLE. FOLLOWING THE AIC-TO-AIC EXCHANGE, NO FURTHER CONTROLLER RELATED ALARMS OCCURRED. PUMP POSITION WAS OPTIMIZED UNDER FLUOROSCOPY, AND HRPCI WAS COMPLETED WITHOUT ADDITIONAL IMPELLA-RELATED ISSUES. THE PATIENT SURVIVED TO EXPLANT. THE REPORTED EVENTS ARE PLACEMENT SIGNAL ISSUES, CONTROLLER FAILURE, DEVICE REVISION OR REPLACEMENT, AND HEMODYNAMIC INSTABILITY. THE AIC WILL BE CONSERVATIVELY REPORTED FOR SERIOUS INJURY DUE TO TEMPORARY HEMODYNAMIC SUPPORT INTERRUPTION DURING THE EXCHANGE; HOWEVER, THE EXCHANGE WAS PERFORMED WITH NO CONSEQUENCE TO THE PATIENT, AND SUPPORT WAS RESUMED WITHOUT ANY KNOWN ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133451 IMPELLA CONTROLLER, PACKAGED, US TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 1211527 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention