BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5

    MDR report key: 23936659 · Received December 31, 2025

    Report

    Report Number
    1220648-2025-49748
    Event Type
    Injury
    Date Received
    December 31, 2025
    Date of Event
    December 16, 2025
    Report Date
    January 28, 2026
    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
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY NO PRODUCT WAS RETURNED. THROMBOSIS: IN ORDER TO MAKE A CAUSE DETERMINATION, ALL OF THE CLINICAL DETAILS OUTLINED IN ES2023-0158 WOULD HAVE TO BE PROVIDED. THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. FAILURE TO ADVANCE: THE CAUSE OF THE FAILURE TO ADVANCE WAS DETERMINED TO BE AN ADVERSE EVENT RELATED TO THE ANATOMY OF THE PATIENT SINCE PATIENT HAD CALCIFICATION AND MD BELIEVED VESSEL WAS TOO SMALL TO ADVANCE. DEVICE HISTORY LOT DEVICE LOT: 1991922 DEVICE HISTORY BATCH SUBCOMPONENT LOT: N/A DEVICE HISTORY REVIEW DEVICE SN: (B)(6) PASSED ALL POST STERILE INSPECTION CHECKS.

    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

    IT WAS REPORTED THAT A PATIENT HAS BEEN ON INTRA-AORTIC BALLOON PUMP (IABP) AND VENOARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA ECMO) FOR A PROLONG PERIOD OF TIME. THE PATIENT WAS ALSO ON CONTINUOUS RENAL REPLACEMENT THERAPY FOR RENAL IMPAIRMENT. THE PATIENT ALSO SUFFERED CEREBROVASCULAR ACCIDENT DURING THIS HOSPITAL ADMISSION. PLAN OF CARE FOR PATIENT WAS TO PLACE IMPELLA 5.5, REMOVE IABP, AND WEAN VA ECMO SUPPORT TO EXPLANT, LEAVING IMEPELLA 5.5 FOR HEMODYNAMIC SUPPORT. AFTER MULTIPLE DAYS OF HEPARIN THERAPY PATIENT WAS BROUGHT BACK FOR ATTEMPT AT IMPELLA 5.5 PLACEMENT. ACCESS WAS ACHIEVED THROUGH STANDARD RIGHT AXILLARY GRAFT, PLACEMENT OF WIRE/CATHETER WAS DIFFICULT DUE TO LITTLE ATRIOVENTRICULAR (AV) MOVEMENT. FINALLY ACCESS ACROSS THE AV WAS ACHIEVED. IMPELLA WAS LOADED ON BIOMED 0.018 AND ADVANCED INTO THE GRAFT AND MADE IT COMPLETELY PAST THE ANASTOMOSIS, CONFIRMED BY MEDICAL DOCTOR, BUT WOULD NOT ADVANCE FURTHER. MULTIPLE ATTEMPTS WERE MADE TO ADVANCE THE IMPELLA, PULLING BACK AND ADVANCING, TORQUING AND ADVANCING TO NO ADVANCEMENT OF THE DEVICE. THE MEDICAL DOCTOR ADVISED QUITE A BIT OF RESISTANCE AND BELIEVED VESSEL WAS TO SMALL TO ADVANCE. THE MEDICAL DOCTOR REMOVED THE DEVICE FROM THE GRAFT WITH INTENT OF COVERING IN PROPOFOL AND TRYING AGAIN. AFTER REMOVING THE IMPELLA THERE WAS BIOMATERIAL IN THE INLET AND THEN THE DOCTOR ABORTED THE PROCEDURE DUE TO CONCERN OF DAMAGE TO THE VESSEL ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2792848 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2026773647 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Other