BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5

    MDR report key: 19939050 · Received August 8, 2024

    Report

    Report Number
    1220648-2024-14297
    Event Type
    Injury
    Date Received
    August 8, 2024
    Date of Event
    June 8, 2024
    Report Date
    June 13, 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
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS DISCARDED BY THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF VF/VT/AF/AT HAS BEEN COMPLETED. THE IMPELLA DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT ADDITIONAL CLINICAL DETAILS, THE ROOT CAUSE OF THE REPORTED ISSUES COULD NOT BE DETERMINED. B1 PRODUCT PROBLEM WAS ERRONEOUSLY SELECTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-14297. E4 SHOULD HAVE BEEN LEFT BLANK ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-14297 AS IT IS UNKNOWN IF THE INITIAL REPORTER ALSO SENT THE REPORT TO THE FOOD AND DRUG ADMINISTRATION. G1 REPORTING CONTACT EMAIL REVISED ON MANUFACTURER DEVICE REPORT 1220648-2024-14297 IN ACCORDANCE WITH UPDATED PROCEDURES. G1 REPORTING CONTACT FAX NUMBER WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-14297. H5 WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-14297. H6 MEDICAL DEVICE PROBLEM CODE 2917 WAS ERRONEOUSLY ENTERED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-14297.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA 5.5 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. AFTER THE IMPLANT, THE PATIENT HAD MULTIPLE RUNS OF VENTRICULAR TACHYCARDIA (VT) REQUIRING TWO CARDIOVERSIONS. THE PUMP WAS REPOSITIONED AND PULLED BACK. AFTER THE REPOSITIONING, THE PATIENT HAD LESS ECTOPY, AND SUPPORT CONTINUED. ADDITIONALLY, THE IMPELLA HAD PLACEMENT SIGNAL NOT RELIABLE ALARM. STAFF RECEIVED GUIDANCE TO ADJUST AO SIGNAL. SUPPORT CONTINUED AND PATIENT IS STABLE POST ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2395254 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2024390699 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention