BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN

    MDR report key: 20652417 · Received November 11, 2024

    Report

    Report Number
    1220648-2024-22884
    Event Type
    Death
    Date Received
    November 11, 2024
    Date of Event
    March 31, 2024
    Report Date
    December 26, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION RENAL FAILURE 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. LITERATURE CITATION: NIKOLAOS PATSALIS, KREUTZ, J., GIORGOS CHATZIS, STYLIANI SYNTILA, MARYANA CHOUKEIR, SCHIEFFER, B., & MARKUS, B. (2024). EARLY RISK PREDICTORS OF ACUTE KIDNEY INJURY AND SHORT-TERM SURVIVAL DURING IMPELLA SUPPORT IN CARDIOGENIC SHOCK. SCIENTIFIC REPORTS, 14(1). HTTPS://DOI.ORG/10.1038/S41598-024-68376-W G1 REPORTING CONTACT EMAIL REVISED ON MANUFACTURER DEVICE REPORT 1220648-2024-22884 IN ACCORDANCE WITH UPDATED PROCEDURES. H10 MISSING CITATION ON MANUFACTURER DEVICE REPORT 1220648-2024-22884.

    Additional Manufacturer Narrative · 0

    REFER TO THE LITERATURE. THE IMPELLA DEVICE HAS BEEN DISCARDED BY THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE IS NOT POSSIBLE. SHOULD ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED. INSTRUCTIONS FOR USE STATE THE FOLLOWING: SECTION: 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 CARDIAC OR VASCULAR INJURY (INCLUDING VENTRICULAR PERFORATION).¿

    Description of Event or Problem · 0

    ON 2024-10-17 ABIOMED JAPAN FORWARDED 14 PUBLICATIONS, ONE FROM MARBURG, GERMANY ENTITLED EARLY RISK PREDICTORS OF ACUTE KIDNEY INJURY (AKI) AND SHORT TERM SURVIVAL DURING IMPELLA SUPPORT IN CARDIOGENIC SHOCK, IN WHICH IMPELLA COHORT, THE PREVALENCE OF AKI WAS 60%, IN ACCORDANCE WITH OTHER PUBLISHED DATA 3,17,18. THE DEVELOPMENT OF AKI WAS SIGNIFICANTLY MORE COMMON IN PATIENTS WITH CHRONIC KIDNEY DISEASE, POSSIBLY REFLECTING A REDUCED COMPENSATORY ABILITY CAUSED BY THE DEVELOPMENT OF CHRONIC RENAL ORGAN DAMAGE. DATA FROM 50 PATIENTS WERE ANALYZED. THE 30-DAY MORTALITY OF THE WHOLE COHORT WAS 22%. IT IS UNKNOWN IF THE CAUSE OF DEATHS WERE RELATED TO THE IMPELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1722281 UNKNOWN TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown Death