BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA 5.0

    MDR report key: 13442045 · Received February 3, 2022

    Report

    Report Number
    1220648-2022-01268
    Event Type
    Death
    Date Received
    February 3, 2022
    Date of Event
    April 21, 2021
    Report Date
    November 29, 2024
    Manufacturer
    ABIOMED INC.
    Product Code
    OZD
    UDI-DI
    813502010053
    PMA / PMN Number
    P1400003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MEDICAL CENTER IN (B)(6) DISCARDED THE IMPELLA PRODUCT A YEAR PRIOR. NO INVESTIGATION IS POSSIBLE. THE DATA SHARED BY THE (B)(6) REGISTRY DID NOT FURNISH ALL CLINICAL DETAILS REQUESTED. SHOULD MORE INFORMATION BE SHARED THAT LEADS TO A ROOT CAUSE, A FINAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS. ADDITIONAL INFORMATION REVIEWED AS PART OF REMEDIATION INDICATED THE PATIENT HAD AN EPISODE OF TACHYCARDIA, THROMBUS AND THE PATIENT EXPIRED. SECTIONS B2, B3, B5, H1 AND H6 HAVE BEEN UPDATED. G1 REPORTING CONTACT EMAIL UPDATED TO CURRENT INFORMATION. D6A, D6B IMPLANT AND EXPLANT DATES ADDED. D7A SINGLE-USE UPDATED. E1 FACILITY PHONE UPDATED FOLLOWING CORRECTION HAVE BEEN MADE: F6 (DATE USER FACILITY OR IMPORTER BECAME AWARE OF EVENT) AND F8 (DATE OF THIS REPORT) HAVE BEEN CORRECTED TO BLANK. G4 (PMA/510(K)NUMBER) INCORRECTLY REPORTED AS P1400003 AND HAVE BEEN UPDATED TO P140003.

    Description of Event or Problem · 0

    THE MEDICAL CENTER IN (B)(6) HAD AN IMPELLA 5.0 PLACED FOR SUPPORT ESCALATED FROM AN IMPELLA CP. THE SUPPORT WAS SUCCESSFUL IN (B)(6) 2021. IN (B)(6) OF 2022 THE (B)(6) REGISTRY NOTED MULTIPLE INJURIES DURING THE TIME OF IMPELLA SUPPORT. THERE WAS ACCESS SITE BLEEDING AND LIMB ISCHEMIA WHICH WAS NOTED TO BE TREATED AND ATTRIBUTE TO THE USE OF IMPELLA. THE BLEEDING WAS TREATED BY RED BLOOD CELL INFUSION AND THE LIMB THROMBOSIS WAS TREATED BY REMOVAL OF THROMBUS.

    Description of Event or Problem · 0

    REMEDIATION REVIEW OF THE INFORMATION SUPPLIED INDICATED THAT THE PATIENT HAD AN EPISODE OF VENTRICULAR TACHYCARDIA UPON RETURNING TO THE INTENSIVE CARE UNIT (ICU) AFTER THE IMPELLA 5.0 HAD BEEN PLACED. IT WAS REPORTED THAT THE POSITION OF THE IMPELLA WAS ADJUSTED AND CONFIRMED THROUGH ECHOCARDIOGRAM. THE INFORMATION ALSO NOTED THE PATIENT EXPIRED. 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
    1749695 IMPELLA 5.0 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED INC. IMPELLA 5.0 PUMP SET, JAPAN 2022041417 813502010053

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention| D ECMO