BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5 WITH SMARTASSIST S2 SET, US

    MDR report key: 24622285 · Received March 17, 2026

    Report

    Report Number
    1220648-2026-05479
    Event Type
    Injury
    Date Received
    March 17, 2026
    Date of Event
    November 16, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 0

    A 58-YEAR-OLD MALE PATIENT WITH A HISTORY OF CARDIOMYOPATHY PRESENTING IN SCAI STAGE D SHOCK REQUIRED ONGOING MECHANICAL CIRCULATORY SUPPORT, INITIALLY WITH VA ECMO AND SUBSEQUENTLY WITH AN IMPELLA 5.5 ON (B)(6). THE PATIENT¿S COMORBIDITIES INCLUDED CORONARY ARTERY DISEASE (CAD) STATUS POST CORONARY ARTERY BYPASS GRAFT (CABG) X 1 (2017), HYPERTENSION/HYPERLIPIDEMIA (HTN/HLD), AND STAGE 4 CHRONIC KIDNEY DISEASE (CKD). DURING SUPPORT, THE CLINICAL TEAM REPORTED A PLACEMENT SIGNAL ISSUE, IN WHICH THE PLACEMENT WAVEFORM WAS NOT RELIABLY DISPLAYED ON THE AIC CONSOLE, ALTHOUGH MOTOR CURRENT AND FLOWS REMAINED WITHIN EXPECTED RANGES FOR THE SELECTED P LEVEL, AND ECHOCARDIOGRAPHY CONFIRMED APPROPRIATE PUMP POSITIONING. NO CONSOLE REPLACEMENT WAS REQUIRED, AND THE DEVICE REMAINED IN USE. DURING THE SAME SUPPORT PERIOD, THE PATIENT EXPERIENCED SUSTAINED VENTRICULAR TACHYCARDIA REQUIRING SYNCHRONIZED CARDIOVERSION, WHICH RESOLVED WITHOUT FURTHER SEQUELAE AND WITH NO ALLEGATIONS OF DEVICE INVOLVEMENT. ON (B)(6), THE IMPELLA 5.5 WAS EXCHANGED DUE TO SUPPORT NEEDS AND DEVICE MANAGEMENT CONSIDERATIONS. THE PATIENT EVENTUALLY STABILIZED, WAS SUCCESSFULLY WEANED FROM MECHANICAL CIRCULATORY SUPPORT, AND THE IMPELLA 5.5 WAS REMOVED WITHOUT INCIDENT ON (B)(6) 2025. BASED ON THE AVAILABLE CLINICAL AND DIAGNOSTIC INFORMATION, THE PLACEMENT SIGNAL UNRELIABILITY AND VT EPISODE APPEAR UNRELATED TO ANY MALFUNCTION OF THE IMPELLA 5.5. THE PLACEMENT SIGNAL ISSUE DID NOT CORRELATE WITH ANY ABNORMAL HEMODYNAMIC PERFORMANCE, AND IMAGING CONFIRMED CORRECT PUMP POSITIONING. THE SUSTAINED VT WAS CONSISTENT WITH THE PATIENT¿S UNDERLYING SEVERE CARDIAC DISEASE, PRIOR ARRHYTHMIAS, AND ONGOING MULTIORGAN INSTABILITY RATHER THAN A DEVICE MEDIATED EVENT. THE IMPELLA 5.5 CONTINUED TO FUNCTION WITHIN EXPECTED PARAMETERS, AND NO DEVICE DEFECT WAS IDENTIFIED. THE DEVICE WAS ULTIMATELY SUCCESSFULLY WEANED AND EXPLANTED, SUPPORTING THE CONCLUSION THAT THE EVENTS OBSERVED WERE SECONDARY TO THE PATIENT¿S CRITICAL CARDIOVASCULAR CONDITION RATHER THAN IMPELLA MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680966 IMPELLA 5.5 WITH SMARTASSIST S2 SET, US TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026731298 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention