BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24833006 · Received April 9, 2026

    Report

    Report Number
    1220648-2026-06588
    Event Type
    Injury
    Date Received
    April 9, 2026
    Date of Event
    April 1, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    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

    ADDITIONAL INFORMATION HAS BEEN PROVIDED IN D9. CORRECTED INFORMATION HAS BEEN PROVIDED IN D4 AND H3. LOW PUMP FLOW: THE CAUSE OF THE LOW PUMP FLOW WAS NOT ESTABLISHED AS NO DATA LOGS WERE RETURNED FOR ANALYSIS, NO DEFECTS WERE OBSERVED ON RETURNED PRODUCT, AND LIMITED INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN PROVIDED IN B5. CORRECTED INFORMATION HAS BEEN PROVIDED IN D4(PRIMARY UDI NUMBER) AND UPDATED.

    Additional Manufacturer Narrative · 0

    ADDED D3 MANUFACTURER FAX WAS OMITTED DURING INITIAL AND PREVIOUS FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 0

    COMPLAINT CODING WAS UPDATED TO BETTER REFLECT THE REPORTED EVENT. CONSEQUENTLY, SECTION H6 HEALTH EFFECT CLINICAL/IMPACT CODES WERE UPDATED/CORRECTED AND REPOPULATED ACCORDINGLY

    Additional Manufacturer Narrative · 0

    THIS IS ONE OF THREE RELATED REPORTS. THIS REPORT REPRESENTS THE SECOND IMPELLA CP AND OTHER REPORTS WILL BE SUBMITTED TO REPRESENT THE OTHER IMPELLA CP PUMPS. 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

    ADDITIONAL INFORMATION RECEIVED INDICATES, PT PRESENTED WITH AMI CGS. POSSIBLE LV THROMBUS ON LV GRAM. RULED OUT ON TTE WITH DEFINITY CONTRAST. PROCEEDED WITH IMPELLA. IMPELLA (SN (B)(6)) INSERTED AND STARTED ON AUTO. FLOWS AND WAVEFORMS NORMAL UNTIL RAMPED UP TO 2.5 L/MIN, THEN SUDDEN DROP IN FLOW AND LV TRACING. SUCTION ON P-2. CONCERN DEVICE COULD BE STUCK UNDER PAP MUSCLE. DEVICE REMOVED. RAN IN STERILE WATER. REINSERTED AND STARTED ON AUTO. AGAIN UNABLE TO ACHIEVE FLOW DESPITE PROPER POSITIONING. CONCERN FOR CLOT INGESTION. IMPELLA REMOVED. CARDIAC ARREST, CPR IN CATH LAB. ROSC ACHIEVED. 2ND CP DEVICE (SN (B)(6)) PREPPED AND INSERTED. STARTED ON AUTO, FLOWS UP TO 3L / MIN WITH APPROPRIATE LV TRACING, THEN SUDDEN LOSS OF FLOW AND DROP IN LV PRESSURES. SUCTION ON P-2. DECISION TO REMOVE IMPELLA AND CANNULATE VA ECMO.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA CP DEVICE WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN A 58-YEAR-OLD FEMALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS), SCAI SHOCK STAGE C, WITH A HISTORY OF KNOWN CORONARY ARTERY DISEASE. A POSSIBLE LEFT-VENTRICULAR THROMBUS WAS INITIALLY SUSPECTED ON LEFT-VENTRICULAR ANGIOGRAPHY BUT WAS RULED OUT BY TRANSTHORACIC ECHOCARDIOGRAPHY WITH DEFINITY CONTRAST, AND THE TEAM PROCEEDED WITH IMPELLA SUPPORT. THE IMPELLA WAS INSERTED AND INITIATED IN AUTO MODE. INITIAL FLOWS AND WAVEFORMS WERE APPROPRIATE; HOWEVER, WHEN SUPPORT WAS INCREASED TO 2.5 L/MIN, THERE WAS AN ABRUPT LOSS OF FLOW AND LEFT-VENTRICULAR PRESSURE TRACING WITH SUCTION NOTED AT P-2. THERE WAS CONCERN THAT THE DEVICE MAY HAVE BEEN POSITIONED BENEATH THE PAPILLARY MUSCLE. THE DEVICE WAS REMOVED, FLUSHED IN STERILE WATER, REINSERTED, AND RESTARTED IN AUTO MODE. DESPITE APPROPRIATE POSITIONING, ADEQUATE FLOW COULD NOT BE ACHIEVED, RAISING CONCERN FOR POSSIBLE CLOT INGESTION, AND THE IMPELLA WAS REMOVED. THE PATIENT SUBSEQUENTLY EXPERIENCED CARDIAC ARREST IN THE CATHETERIZATION LABORATORY. CARDIOPULMONARY RESUSCITATION WAS INITIATED, AND RETURN OF SPONTANEOUS CIRCULATION WAS ACHIEVED. A SECOND IMPELLA CP DEVICE WAS PREPARED AND INSERTED. THE DEVICE WAS STARTED IN AUTO MODE WITH FLOWS UP TO APPROXIMATELY 3.0 L/MIN AND APPROPRIATE LEFT-VENTRICULAR WAVEFORMS, FOLLOWED AGAIN BY SUDDEN LOSS OF FLOW AND DROP IN LEFT-VENTRICULAR PRESSURES WITH SUCTION NOTED AT P-2. A DECISION WAS MADE TO REMOVE THE IMPELLA AND PROCEED WITH VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA-ECMO) CANNULATION. DURING THIS PERIOD, THE AUTOMATED IMPELLA CONTROLLER (AIC) ALARMED FOR ¿PURGE PRESSURE HIGH,¿ FOLLOWED BY ¿PURGE FLOW BLOCKED.¿ TROUBLESHOOTING WAS ATTEMPTED, INCLUDING PURGE CASSETTE EXCHANGE, WITHOUT RESOLUTION. TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS PLACED IN THE PURGE LINE, AND THE PURGE SOLUTION WAS CHANGED FROM BICARBONATE-BASED TO HEPARIN-BASED PURGE FLUID. THE MANAGING PHYSICIAN WAS AWARE AND CONSIDERED DEVICE REMOVAL IF THE PURGE ISSUE DID NOT RESOLVE. THE PATIENT SURVIVED TO EXPLANT. THE REPORTED EVENTS ARE LOW PUMP FLOW, PLACEMENT SIGNAL ISSUES, MEDICAL DEVICE REMOVAL, ADDITIONAL DEVICE REQUIRED, AND HEMODYNAMIC INSTABILITY. THE DEVICE WILL BE CONSERVATIVELY REPORTED FOR SERIOUS INJURY DUE TO TEMPORARY HEMODYNAMIC SUPPORT INTERRUPTION DURING DEVICE REMOVAL; HOWEVER, THE REMOVAL WAS PERFORMED WITH NO CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284324 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027853466 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1