BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5

    MDR report key: 23089025 · Received September 18, 2025

    Report

    Report Number
    1220648-2025-46594
    Event Type
    Injury
    Date Received
    September 18, 2025
    Date of Event
    August 20, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS CODES HAVE BEEN UPDATED TO REFLECT INVESTIGATION CLOSURE. INVESTIGATION SUMMARY ==> NO PRODUCT WAS RETURNED. ARRHYTHMIA: IN ORDER TO MAKE A CAUSE DETERMINATION, ADDITIONAL CLINICAL DETAILS WOULD HAVE TO BE PROVIDED. THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. PUMP SUCTION: NO PRODUCT WAS RETURNED. ORTHOSTATIC SUCTION EVENTS WERE PRESENT IN THE MORNING. AFTER REVIEWING LOGS, SUCTION ALARMS AND POSITION UNKNOWN ALARMS WERE OBSERVED THAT RESOLVE. NO MOTOR CURRENT (MC) SPIKES OUTSIDE OF P-LEVEL CHANGES. THE CAUSE OF THE SUCTION EVENT WAS LIKELY PATIENT CONDITION RELATED PER CLINICAL SINCE THE SUCTION WAS ORTHOSTATIC IN NATURE, THE PATIENT HAD VERY LOW CENTRAL VENOUS PRESSURE (CVP), AND LOG REVIEW SHOWED NO ABNORMALITIES CONFIRMING THE SUCTION RESOLVED. DEVICE HISTORY LOT ==> DEVICE LOT: 1932174. DEVICE HISTORY REVIEW ==> DEVICE (SN: (B)(6)) PASSED ALL POST STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    A.5 IS UNKNOWN. THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER. THEREFORE, THE INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT WITH CARDIOMYOPATHY WAS IMPLANTED WITH AN IMPELLA 5.5 FOR MECHANICAL CIRCULATORY SUPPORT WHILE AWAITING A HEART TRANSPLANT. ON THE SECOND DAY OF SUPPORT, IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A NEW ONSET OF ECTOPY. AN ECHOCARDIOGRAM AND CHEST X-RAY WERE ORDERED TO EVALUATE THE POSITION OF THE IMPELLA 5.5 AND THE SWAN. IT WAS ALSO NOTED THAT THE PATIENT¿S ARM DISTAL TO THE IMPELLA INSERTION WAS SWOLLEN AND THE IMPELLA ACCESS SITE WAS REDRESSED WITH PRESSURE DRESSING. THE FOLLOWING DAY, IT WAS REPORTED THAT THERE WERE SUCTION EVENTS WHICH WERE ORTHOSTATIC IN NATURE AND IT WAS NOTED THAT PATIENT HAD A VERY LOW CENTRAL VENOUS PRESSURE. AS A RESULT OF THE HYPOTENSION ISSUES, THE PATIENT¿S LASIX INTRAVENOUS DRIP WAS DISCONTINUED. DUE TO THE PATIENT¿S RENAL FUNCTION AND LIKELIHOOD FOR DIALYSIS, THE PATIENT WAS DEEMED TO NOT BE A CANDIDATE FOR A HEART TRANSPLANT BUT WAS APPROVED FOR A DURABLE LEFT VENTRICLE ASSIST DEVICE (LVAD). THE PATIENT SUCCESSFULLY UNDERWENT SURGERY FOR AN LVAD AT WHICH TIME THE IMPELLA 5.5 WAS SUCCESSFULLY WEANED AND EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2835836 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2026687549 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Other