BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5

    MDR report key: 23163808 · Received September 28, 2025

    Report

    Report Number
    1220648-2025-46955
    Event Type
    Injury
    Date Received
    September 28, 2025
    Date of Event
    August 16, 2025
    Report Date
    January 7, 2026
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    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

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

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY PUMP WAS NOT RETURNED FOR INVESTIGATION. USB DATA DRIVE WAS RETURNED WITH DATA LOGS. DATA LOG REVIEW WAS NOT REQUIRED FOR THIS CASE RUN. PERI-PROCEDURAL ADVERSE EVENT: AORTIC VALVE INSUFFICIENCY/ REGURGITATION: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. VENTRICULAR FIBRILLATION, ARRHYTHMIA: 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. DEVICE HISTORY LOT DEVICE BATCH: 1905620 DEVICE HISTORY BATCH SUBCOMPONENT LOT: NA DEVICE HISTORY REVIEW THE PUMP SN561304A PASSED ALL POST STERILE INSPECTION CHECKS.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT A PATIENT PRESENTED FOR SUCCESSFUL 3 VESSEL CORONARY ARTERY BYPASS GRAFTING HOWEVER QUICKLY DECOMPENSATED AFTER CHEST WAS CLOSED. CARDIOPULMONARY RESUSCITATION PERFORMED AND PATIENT REOPENED. DECISION FOR IMPELLA 5.5 INSERTION WAS MADE. THE 5.5 WAS SUCCESSFULLY PLACED. DURING SUPPORT IT WAS NOTED HAT THE PATIENT EXPERIENCED SEVERAL BOUTS OF NON-SUSTAINED VENTRICULAR TACHYCARDIA (VT). PUMP WAS SHALLOW HOWEVER CARDIOLOGY DID NOT WANT TO REPOSITION. THE PATIENT WITH CONTINUED WITH BURSTS OF VT YET SELF RESOLVING. ADDITIONALLY, THE PATIENT HAD ATRIAL FIBRILLATION (AFIB), ATTEMPTED CARDIOVERSION BUT UNSUCCESSFUL, AMIO WAS ON BOARD AND RATE WAS MORE CONTROLLED HOWEVER STILL ATRIAL FIBRILLATION. IT WAS ALSO NOTED THAT THE PATIENT HAD SOME AORTIC INSUFFICIENCY, HOWEVER WAS HEMODYNAMICALLY STABLE. THE 5.5 WAS SUCCESSFULLY WEANED AND EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1469409 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2026626883

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention