BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA 5.5

    MDR report key: 17886292 · Received October 6, 2023

    Report

    Report Number
    1220648-2023-03855
    Event Type
    Death
    Date Received
    October 6, 2023
    Date of Event
    September 9, 2021
    Report Date
    October 29, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS DISCARDED BY THE CUSTOMER AND THEREFORE,¿AN EVALUATION OF THE DEVICE WAS NOT POSSIBLE. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL MDR WILL BE FILED. INSTRUCTIONS FOR USE FOR THE RELATED EVENT ARE AS FOLLOWS: ¿POTENTIAL ADVERSE EVENTS (UNITED STATES) ACUTE RENAL DYSFUNCTION, AORTIC VALVE INJURY, BLEEDING, CARDIOGENIC SHOCK, CEREBRAL VASCULAR ACCIDENT/STROKE, DEATH, HEMOLYSIS, LIMB ISCHEMIA, MYOCARDIAL INFARCTION, RENAL FAILURE, THROMBOCYTOPENIA AND VASCULAR INJURY.¿ THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

    Additional Manufacturer Narrative · 0

    THIS FILE IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS AFTER WHICH MEDICAL SAFETY HAS UPDATED THE REPORT TYPE. CORRECTED INFORMATION FOR THE INITIAL MFR 1220648-2023-03855 WAS PROVIDED.

    Additional Manufacturer Narrative · 0

    D6A AND D6B REVISED FROM THE INITIAL MANUFACTURER DEVICE REPORT 1220648-2023-03855 IN ACCORDANCE WITH UPDATED PROCEDURES. F6/F8-SHOULD HAVE BEEN LEFT BLANK ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-03855 IN ACCORDANCE WITH UPDATED PROCEDURES. G1 REPORTING CONTACT EMAIL REVISED ON MANUFACTURER DEVICE REPORT 1220648-2023-03855 IN ACCORDANCE WITH UPDATED PROCEDURES. G1 REPORTING CONTACT FAX NUMBER WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-03855. H6 INVESTIGATION CONCLUSIONS REVISED FROM THE INITIAL SUBMISSION IN ACCORDANCE WITH UPDATED PROCEDURES.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A 73-YEAR-OLD MALE WITH BIVENTRICULAR FAILURE WAS IMPLANTED WITH AN IMPELLA 5.5 AND RP FOR MECHANICAL CIRCULATORY SUPPORT. THE PATIENT ON IMPELLA SUPPORT EXPERIENCED A LOW PUMP FLOW ON THE 5.5 PUMP, AND IMAGING CONFIRMED THE PRESENCE OF A THROMBUS IN THE LEFT VENTRICLE. DEVICE WAS EXPLANTED AFTER 6 DAYS.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION NOTED CARE WAS WITHDRAWN, AND THE PATIENT EXPIRED. MEDICAL SAFETY REVIEW OF THE EVENT NOTED THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202351 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2022098115

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Other| D| R