BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5

    MDR report key: 24111672 · Received January 19, 2026

    Report

    Report Number
    1220648-2026-01047
    Event Type
    Injury
    Date Received
    January 19, 2026
    Date of Event
    January 12, 2026
    Report Date
    January 19, 2026
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D6B EXPLANT DATE UPDATED. B5 AMENDED TO INCLUDE FURTHER INFORMATION. E4 NUMBER WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS COMPLETED AND NO DEVICE WAS RETURNED. INVESTIGATION SUMMARY: PPAE (THROMBOSIS/ISCHEMIA/THROMBOCYTOPENIA): THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    CLINICAL RATIONALE: A 64-YEAR-OLD MALE UNDERWENT ELECTIVE PLACEMENT OF AN IMPELLA 5.5 DEVICE (SN (B)(6); (B)(4); GU CASE (B)(4)) VIA DIRECT RIGHT SIDED SURGICAL AORTIC ACCESS ON (B)(6) 2026 AT 14:45. WHILE ON SUPPORT, THE PATIENT DEVELOPED MOTTLED BILATERAL UPPER AND LOWER EXTREMITIES WITH FAINT DOPPLER PULSES, AND DOPPLER ULTRASOUND DEMONSTRATED CLOT IN BOTH ARMS AND LEGS. THROMBOSIS, ISCHEMIA, AND THROMBOCYTOPENIA WERE NOTED, AND SUSPECTED HEPARIN INDUCED THROMBOCYTOPENIA (HIT) WAS REPORTED BY NURSING STAFF WITH CONFIRMATORY TESTING PENDING. IMMEDIATE CLINICAL MANAGEMENT DETAILS, INCLUDING ANY PUMP EXCHANGE, CONSOLE TROUBLESHOOTING, OR PURGE ADJUSTMENTS, WERE NOT SPECIFIED. DEVICE PERFORMANCE PARAMETERS, ALARMS, AND DIAGNOSTICS AT THE TIME OF THE EVENT WERE NOT REPORTED. PHYSICAL INSPECTION FINDINGS ARE UNAVAILABLE, AND PRODUCT RETURN STATUS REMAINS UNKNOWN PENDING GFE REVIEW. THE PATIENT REMAINED ON IMPELLA SUPPORT. IT IS UNKNOWN IF THE CLOTS WE PRESENT PRIOR TO THE INITIATION OF IMPELLA SUPPORT AND THERE ARE NO DETAILS REGARDING INTERVENTION. THROMBOCYTOPENIA AND ISCHEMIA ARE CONSISTENT WITH KNOWN DEVICE-RELATED AND PATIENT-RELATED FACTORS DOCUMENTED IN THE INSTRUCTIONS FOR USE (IFU).

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT ON IMPELLA SUPPORT WITH A 5.5 PUMP. THE COMPLAINANT REPORTED THAT CLOTS WERE SUSPECTED ON BOTH ARMS AND LEGS. EXTREMITIES WERE MOTTLED WITH FAINT DOPPLER PULSES. HEPARIN-INDUCED THROMBOCYTOPENIA IS ALSO SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531452 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2026736335 813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention