BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5

    MDR report key: 23897255 · Received December 26, 2025

    Report

    Report Number
    1220648-2025-49464
    Event Type
    Injury
    Date Received
    December 26, 2025
    Date of Event
    September 21, 2025
    Report Date
    December 26, 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
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CLINICAL SYMPTOMS (ARRHYTHMIA): 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 (PAIN): THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. LOW OR BLOCKED PUMP FLOW: THE PUMP WAS NOT RETURNED FOR INVESTIGATION. ACCORDING TO THE CLINICAL DETAILS, LOW FLOW WAS REPORTED ON 04-OCT. DATA LOG SHOWS THE PUMP P-LEVEL WAS REDUCED FROM P8 TO P4 ON 02-OCT WHILE EXPERIENCING SUCTION ALARMS. LATER, FLOW WAS SEEN TO GRADUAL DECREASE BELOW 1 L/MIN, WITH SOME IMPROVEMENT NOTED WHILE RUNNING ON STEADY P4. THERE WAS NO CONCLUSIVE TREND NOTED ON THE PLACEMENT SIGNAL RELATED TO PATIENT CONDITION. NO MOTOR CURRENT SPIKE OR POSITIONING ISSUE WAS NOTED DURING THE TIME OF LOW PUMP FLOW. THE CAUSE OF THE LOW PUMP FLOW WAS NOT DETERMINED WITHOUT RETURNED PRODUCT INVESTIGATION AND SUFFICIENT CLINICAL DETAILS. ACCESS SITE ADVERSE EVENT (HEMATOMA): THE CAUSE OF THE ACCESS SITE ADVERSE EVENT WAS NOT DETERMINED WITHOUT RETURNED PRODUCT INVESTIGATION AND SUFFICIENT CLINICAL DETAILS. DEVICE HISTORY LOT: DEVICE BATCH: 1951078. DEVICE HISTORY BATCH: SUBCOMPONENT LOT: NA. DEVICE HISTORY REVIEW: THE PUMP SN (B)(6) PASSED ALL POST STERILE INSPECTION CHECKS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA 5.5 FOR MECHANICAL CIRCULATORY SUPPORT. DURING SUPPORT, THE PATIENT HAD RUNS OF VENTRICULAR TACHYCARDIA AND A HEMATOMA IN THE RIGHT AXILLARY POCKET. ADDITIONALLY, THE PUMP EXHIBITED LOW FLOW. NO FURTHER INFORMATION WAS PROVIDED. THE PUMP WAS SUCCESSFULLY WEANED AND EXPLANTED, AND THE PATIENT SURVIVED THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1785913 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2026714435 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male Required Intervention