BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5

    MDR report key: 23571187 · Received November 17, 2025

    Report

    Report Number
    1220648-2025-48401
    Event Type
    Injury
    Date Received
    November 17, 2025
    Date of Event
    October 18, 2025
    Report Date
    February 19, 2026
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: (ATRIAL FIBRILLATION, THROMBOSIS/THROMBUS): IN ORDER TO MAKE A CAUSE DETERMINATION, ALL OF THE CLINICAL DETAILS OUTLINED IN (B)(4) WOULD HAVE TO BE PROVIDED. THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. CLINICAL SYMPTOMS (PULMONARY EDEMA, HEMORRHAGE/BLEEDING, PERICARDIAL EFFUSION): THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. PERI-PROCEDURAL ADVERSE EVENT: THE CAUSE OF THE PERI-PROCEDURAL ADVERSE EVENT WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY LOT: DEVICE BATCH: 1894050. DEVICE HISTORY BATCH: SUBCOMPONENT LOT: NA. DEVICE HISTORY REVIEW: THE PUMP (B)(6) PASSED ALL POST STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    B5 UPDATED.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED ADDITIONAL INFORMATION UPON REQUEST: "I BELIEVE THIS PATIENT WAS TRANSFERRED. THERE IS NO FURTHER INFORMATION AVAILABLE."

    Description of Event or Problem · 0

    THE PATIENT WAS PLACED ONTO IMPELLA 5.5 SUPPORT FOR OFF-PUMP CORONARY ARTERY BYPASS. WHILE ON SUPPORT, PATIENT WENT INTO ATRIAL FIBRILLATION THEN WENT BACK IN TO NORMAL SINUS RHYTHM. A FEW DAYS LATER IT WAS REPORTED THAT A COMPUTED TOMOGRAPHY SCAN WAS DONE, SCAN REVEALED LARGE PERICARDIAL EFFUSION (HEMOPERICARDIUM), MODERATE PLEURAL EFFUSION, AND HEMOTHORAX. FURTHERMORE, THE PATIENT WENT BACK FOR WASHOUT, EVACUATED 1L OF BLOOD/CLOTS. THE PATIENT WENT INTO ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE, WAS GIVEN AMIO BOLUS AND STARTED DRIP. CARDIOVERTED X2 WHICH WAS UNSUCCESSFUL SO AN ADDITIONAL AMIO BOLUS WAS GIVEN. THE PATIENT WAS LATER SUCCESSFULLY EXPLANTED AND SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280344 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2026635224 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention