BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA 5.5

    MDR report key: 23443673 · Received October 31, 2025

    Report

    Report Number
    1220648-2025-31908
    Event Type
    Death
    Date Received
    October 31, 2025
    Date of Event
    July 15, 2024
    Report Date
    October 31, 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. CLINICAL REPORTED MULTIPLE BALLOONS, WIRES, AND SHOCKWAVE WERE USED. CLINICAL REPORTED IMPELLA OPTICAL SENSOR WAS PULLED BACK FROM LMAIN PRIOR TO SHOCKWAVING HOWEVER DISTANCE BETWEEN SHOCKWAVE AND DEVICE WAS NOT SPECIFIED. THE PUMP WAS RETURNED FOR INVESTIGATION. NO PHYSICAL ABNORMALITIES WERE OBSERVED. THE PUMP PASSED THE LASER CONTINUITY TEST FOR THE OPTICAL SENSOR. THE OPTICAL SIGNAL PARAMETERS INDICATE A HARD FAILURE TREND ON RETURNED PRODUCT. DATA LOG SHOWS THE PLACEMENT SIGNAL NOT RELIABLE ALARM ALONG AND ALL 5S PARAMETER WAS DOWN WHICH INDICATE HARD FAILURE OF THE SENSOR. PLACEMENT SIGNAL WAS LOST IMMEDIATELY AFTER THE SHOCKWAVE DEVICE WAS USED. THE CAUSE OF THE OPTICAL SIGNAL ISSUE WAS A DAMAGED SENSOR DUE TO THE SHOCKWAVE DEVICE INTERACTION. PER IFU 1000349 RI USE WITH SHOCKWAVE CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER AT A DISTANCE OF LESS THAN 20 MM BETWEEN THE OPTICAL SENSOR AND IVL DEVICE MAY INTERFERE WITH OR DAMAGE THE IMPELLA OPTICAL SENSOR. 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.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THE PATIENT WAS ON IMPELLA 5.5 SUPPORT AND THAT A CORONARY SHOCKWAVE WAS USED. WHILE "SHOCKING" THE LEFT VENTRICLE, A PLACEMENT SIGNAL ALARM WAS TRIGGERED WITH THE LEFT VENTRICLE PLACEMENT SIGNAL BEING LOST. THE PUMP WAS FUNCTIONING PROPERLY OTHERWISE. THE DOCTOR DECIDED TO LEAVE THE PUMP AS IT WAS AND MONITOR. NO KNOWN PATIENT HARM OR INJURY HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1385803 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2025454961 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Death AUTOMATED IMPELLA CONTROLLER.