BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA 5.5

    MDR report key: 22951081 · Received September 3, 2025

    Report

    Report Number
    1220648-2025-31198
    Event Type
    Death
    Date Received
    September 3, 2025
    Date of Event
    June 13, 2025
    Report Date
    October 20, 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
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF OPTICAL SIGNAL ISSUES, PER FDA RECOMMENDATION. THE INVESTIGATION HAS BEEN COMPLETED. THERE WAS NO PRODUCT RETURNED. OPTICAL SIGNAL ISSUE. THE CLINICAL STATES THAT "AROUND THE SAME TIME AS THE TUBING SNAPPING, DEVICE LOST AORTA AND LEFT VENTRICLE PLACEMENT SIGNALS. MOTOR CURRENT PULSATILE AND FLOW CONSISTENT. CUSTOMER SERVICE CENTER CALLED AND RELAYED THAT PURGE SYSTEM AND OPTICAL SENSOR ARE UNRELATED. AFTER SOME TIME, CHRONIC CARE MANAGEMENT PUSHED CATHETER PLUG TO ENSURE IT WAS FULLY ENGAGED WITH AUTOMATED IMPELLA CONTROLLER (AIC). PLACEMENT SIGNAL RETURNED IMMEDIATELY. THE DATA LOGS SHOW THAT THERE WERE PLACEMENT SIGNAL NOT RELIABLE (PSNR) ALARMS WHERE CONTRAST DECREASES, GAIN INCREASES, LAMP INCREASES, SIGNAL-TO-NOISE RATIO (SNR) DECREASES, AND LIGHT WAS STABLE. THIS SHORTLY RESOLVES. BASED ON THE DATA LOGS AND CLINICAL DETAILS PROVIDED, THE ROOT CAUSE OF THE OPTICAL SIGNAL ISSUE IS MOST LIKELY DUE TO A SMALL AIR GAP BETWEEN THE AIC AND PUMP PLUG. PURGE LEAK - CASSETTE. THE CLINICAL STATES THAT "PURGE TUBING SNAPPED NEAR YELLOW LEUR DURING TRANSPORT FROM OR TO UNIT IMMEDIATELY POST-IMPLANT. RN QUICKLY REPLACED CASSETTE AND TUBING TO RESOLVE PURGE SYSTEM OPEN ALARM." THE DATA LOGS SHOW THAT AROUND THAT TIME THERE WERE PURGE SYSTEM OPEN ALARMS WITH PURGE FLOW INCREASING. BASED ON THE CLINICAL DESCRIPTION, THE ROOT CAUSE OF THE PURGE LEAK - CASSETTE WAS MOST LIKELY DUE TO USE AS THE PURGE TUBING SNAPPED DURING TRANSPORT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE SUSPECT PRODUCT AND HISTORICAL COMPLAINT DATA WAS CONDUCTED. THIS REVIEW REVEALED THAT THE PRODUCT MET ALL MANUFACTURING RELEASE CRITERIA, AND NO PRODUCT DEFICIENCIES WERE IDENTIFIED AT THE TIME THE PRODUCT WAS MANUFACTURED AND RELEASED TO THE CUSTOMER. ALL PERTINENT INFORMATION AVAILABLE TO ABIOMED HAS BEEN SUBMITTED AT THIS TIME. H6 UPDATED. B7 OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS UPDATED. D10 CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES UPDATED.

    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.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT A PATIENT WITH AN IMPELLA 5.5 WAS REPORTED TO HAVE LOST AORTIC AND LEFT VENTRICLE PLACEMENT SIGNALS. MOTOR CURRENT PULSATILE AND FLOW WERE CONSISTENT. THE CATHETER PLUG WAS PUSHED TO ENSURE IT WAS FULLY ENGAGED WITH AIC AND THE PLACEMENT SIGNAL RETURNED. IT WAS FURTHER REPORTED THAT CARE WAS WITHDRAWN AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1335978 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2026664383 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Death| R AUTOMATED IMPELLA CONTROLLER