BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 21819359 · Received April 10, 2025

    Report

    Report Number
    1220648-2025-27388
    Event Type
    Injury
    Date Received
    April 10, 2025
    Date of Event
    April 1, 2025
    Report Date
    September 22, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INSTRUCTIONS FOR USE: 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).¿ B1 ADVERSE EVENT WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27388. B2 WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27388. H1 TYPE OF REPORTABLE EVENT WAS ERRONEOUSLY SELECTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27388. H6 HEALTH EFFECT - CLINICAL CODE 4582 WAS ERRONEOUSLY ENTERED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27388. H6 HEALTH EFFECT - IMPACT CODE 4614 WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27388. H10 INSTRUCTIONS FOR USE WERE INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27388. NO CHANGES IN INVESTIGATION RESULTS PREVIOUSLY REPORTED IN MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27388-1.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WILL NOT BE RECEIVED FROM THE CUSTOMER. THEREFORE, INVESTIGATION OF THE DEVICE IS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED. THE FOLLOWING SECTIONS ARE BLANK AS LITTLE DETAILS WERE PROVIDED IN LITERATURE ARTICLE: D.4 MODEL NUMBER, CATALOG NUMBER, SERIAL NUMBER, LOT NUMBER, EXPIRATION DATE AND UNIQUE IDENTIFIER (UDI) # ARE UNKNOWN. D.6A AND D.6B IMPLANT AND EXPLANT DATES ARE UNKNOWN. H.4 DEVICE MANUFACTURE DATE IS UNKNOWN.

    Additional Manufacturer Narrative · 0

    NO PRODUCT OR DATA LOGS WERE RETURNED FOR EVALUATION. HIGH PURGE PRESSURE: CLINICAL DETAILS NOTED THAT IMPELLA CP WAS USED WITH ARGATROBAN AS A PURGE SOLUTION AND DECREASED PURGE FLOW WAS OBSERVED. PUMP WAS REPLACED AND PURGE WAS SWITCHED TO SODIUM BICARBONATE AND PURGE FLOWS AND PRESSURES WERE ABLE TO BE MAINTAINED. THE ROOT CAUSE OF THE HIGH PURGE PRESSURE COULD NOT BE DEFINITIVELY DETERMINED AS NO PRODUCT OR LOG WERE RETURNED FOR EVALUATION. THROMBOCYTOPENIA: A FAILURE MODE OF "THROMBOCYTOPENIA" WAS ADDED TO THE INVESTIGATION BASED ON CLINICAL DETAILS THAT PATIENT WAS EXPERIENCING HEPARIN-INDUCED THROMBOCYTOPENIA WHILE ON IMPELLA SUPPORT. THE CAUSE OF THE THROMBOCYTOPENIA WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A LITERATURE ENTRY "A CASE OF SEVERE HEART FAILURE USING BICARBONATE BASED IMPELLA PURGE SOLUTION AS AN ALTERNATIVE TO HEPARIN" THAT AN IMPLANTED IMPELLA CP PUMP DEVELOPED LOW PURGE FLOW PROMPTING PUMP REPLACEMENT. THERE WAS NO NOTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1161928 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown Other