BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP

    MDR report key: 20552011 · Received October 28, 2024

    Report

    Report Number
    1220648-2024-21367
    Event Type
    Death
    Date Received
    October 28, 2024
    Date of Event
    April 6, 2022
    Report Date
    October 13, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011609
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

    Additional Manufacturer Narrative · 0

    H6 : ADDED "3243-STRESS PROBLEM IDENTIFIED" TO CODING TO ACCOUNT FOR KINK.

    Additional Manufacturer Narrative · 0

    HIGH PRESSURE PURGE: SOME EVIDENCE OF BIOMATERIAL WAS SEEN IN THE PURGE GAP. THE PUMP WAS RUN IN THE LAB AND THE HIGH PURGE PRESSURE WAS NOT REPRODUCED, WITH PURGE PRESSURE AT AROUND 750 MMHG. THE DATA LOGS HOW A SUDDEN SPIKE IN PURGE PRESSURE INDICATIVE OF A POTENTIAL KINK IN THE LINE, THUS THE ROOT CAUSE IS MOST LIKELY A PURGE LINE KINK. VT/VF: THIS COMPLAINT HAS BEEN IDENTIFIED AS PART OF A RETROSPECTIVE REVIEW. DUE TO LIMITED CLINICAL INFORMATION AND LACK OF AVAILABLE DATA/PRODUCT THE ROOT CAUSE OF THIS PATIENT CODING INVESTIGATION IS NOT DETERMINED. B2 SELECTION DEATH WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-21367. G1 REPORTING CONTACT EMAIL REVISED ON MANUFACTURER DEVICE REPORT 1220648-2024-21367 IN ACCORDANCE WITH UPDATED PROCEDURES. H1 TYPE OF REPORT WAS ERRONEOUSLY SELECTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-21367. H6 TYPE OF INVESTIGATION CODE 4121 AND 4112 WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER1220648-2024-21367-1. H10 INVESTIGATION RESULTS WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-21367-1.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK NEEDING AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. DURING IMPLANTATION, THE PATIENT CODED DURING THE PROCESS REQUIRING CARDIOPULMONARY RESUSCITATION AND FOUR MORE SHOCKS, RETURN OF SPONTANEOUS CIRCULATION WAS OBTAINED. IN ADDITION, THE COMPLAINANT REPORTED HIGH PURGE PRESSURE DURING PATIENT SUPPORT. ADDITIONAL INFORMATION WAS PROVIDED THAT NOTED THE PATIENT EXPIRED. THERE WAS NO REPORTED RELATION OF THE IMPELLA WITH THE PATIENT'S OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1197039 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2023185047 00813502011609

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention| L| D