BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5

    MDR report key: 23176787 · Received September 30, 2025

    Report

    Report Number
    1220648-2025-47011
    Event Type
    Injury
    Date Received
    September 30, 2025
    Date of Event
    August 30, 2025
    Report Date
    September 29, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    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

    CORRECTIONS: E4, G4, H6.

    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

    THE INVESTIGATION OF THE REPORTED FAILURE MODE HAS BEEN COMPLETED. NO PRODUCT WAS RECEIVED FOR EVALUATION. TACHYCARDIA: THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. EPISTAXIS/THROMBOCYTOPENIA: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. HEMATURIA: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. MAJOR BLEED: THE CAUSE OF THE BLEEDING WAS NOT DETERMINED AS IT OCCURRED AT A NON-IMPELLA SITE, AND NO PHYSICAL PRODUCT WAS RETURNED. PUMP SUCTION: DATA LOG REVIEW CONFIRMS SUCTION OCCURRING AT THE TIME WHICH IT WAS REPORTED. AT THIS TIME, PLACEMENT SIGNAL IS TRENDING DOWN. THERE WERE NO OTHER ABNORMALITIES IN THE DATA LOGS NOTED AT THIS TIME, A SUCTION DID NOT OCCUR FOR THE REMAINDER OF THE CASE, INDICATING THAT ADMINISTERING FLUID RESOLVED THE ISSUE. THE CAUSE OF THE SUCTION WAS MOST LIKELY RELATED TO THE PATIENTS CONDITION, AS PLACEMENT SIGNAL WAS TRENDING DOWN AT THE TIME OF SUCTION, AND IT RESOLVED AFTER ADMINISTERING FLUID, INDICATED THAT THE PATIENT LIKELY HAD VOLUME ISSUES. DEVICE HISTORY LOT: DEVICE LOT NUMBER: 1951097. DEVICE HISTORY BATCH: SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW: PUMP SN (B)(6) PASSED ALL POST STERILE INSPECTION CRITERIA.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT AN IMPELLA 5.5 PUMP EXPERIENCED BLEEDING, SUCTION EVENT AND HEMOLYSIS DURING PATIENT SUPPORT. THE PATIENT RECEIVED FLUIDS AS SUCTION WAS NOTED. ADDITIONALLY, THE PATIENT EXPERIENCED VENTRICULAR TACHYCARDIA AND WAS SHOCKED. IT WAS NOTED THAT THE PATIENT HAD SIGNIFICANT BLEEDING FROM THE NOSE AND MOUTH WITH AN UNKNOWN CAUSE. ANTICOAGULATION WAS PAUSED. THE PATIENT WAS POSITIVE FOR HEPARIN INDUCED THROMBOCYTOPENIA AND CONTINUED CONTINUOUS RENAL REPLACEMENT THERAPY. THERE WAS A REPORT OF PINK-TINGED URINE. THERE WAS NO FOLEY AVAILABLE, SO THE TEAM WAS UNABLE TO EVALUATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1409548 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2026716252

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention