BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA RP

    MDR report key: 20767523 · Received November 24, 2024

    Report

    Report Number
    1220648-2024-24135
    Event Type
    Injury
    Date Received
    November 24, 2024
    Date of Event
    November 10, 2024
    Report Date
    January 7, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    PYX
    UDI-DI
    00813502011869
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MANUFACTURER DEVICE REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE HEMOLYSIS, RENAL FAILURE, AND POSITIONING ISSUE HAS BEEN COMPLETED. THE PUMP WAS NOT RETURNED FOR INVESTIGATION. ACCORDING TO THE CLINICAL NOTES, THE PATIENT WAS REPORTED WITH HEMOLYSIS DIAGNOSED BY ELEVATED PLASMA FREE HEMOGLOBIN (PGHB). THIS IS WHEN THE CP PUMP WAS PLACED FOR LEFT SIDE SUPPORT. THE DOCTOR REPORTED THAT THE HEMOLYSIS WAS RESOLVED AFTER THE RP REMOVAL, WHILE THE CP PUMP WAS STILL IN USE. THE DATA LOG SHOWS THAT THE RP HAD PLACEMENT SIGNAL TRENDS AND MOTOR CURRENT TRENDS OBSERVED DURING THE HEMOLYSIS EVENT. ALSO, AT THE TIME OF THE HEMOLYSIS EVENT, SEVERAL SUCTION ALARMS AND THE TRENDING PLACEMENT SIGNAL AND MOTOR CURRENT WERE REPORTED ON THE CP PUMP. ALSO, THE PATIENT WAS ON AND OFF CRRT DURING THE IMPELLA SUPPORT. BASED ON THE DATA LOG REVIEW, THE CAUSE OF THE HEMOLYSIS ISSUE WAS RELATED TO THE PATIENT CONDITION. THE CAUSE OF THE RENAL FAILURE ISSUE WAS RELATED TO THE PATIENT'S CONDITION, AS THERE IS NO CONNECTION BETWEEN HEMOLYSIS AND THE DEVICE'S PERFORMANCE. RP PUMP WAS MALPOSITION ON (B)(6). THE CAUSE OF THE POSITIONING ISSUE WAS MOST LIKELY USE RELATED.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT IN ST ELEVATION MYOCARDIAL INFARCTION WAS IMPLANTED WITH AN IMPELLA RP AND IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED WHILE ON IMPELLA RP SUPPORT, THE PATIENT EXPERIENCED HEMOLYSIS THAT WAS CONFIRMED BY ELEVATED PLASMA FREE HEMOGLOBIN LEVELS. IT WAS LATER REPORTED THE PATIENT HAD AN ACUTE KIDNEY INJURY THAT OCCURRED FROM THE HEMOLYSIS THAT OCCURRED DURING IMPELLA RP SUPPORT. THE PATIENT WAS PLACED ON CONTINUOUS RENAL REPLACEMENT THERAPY AS A RESULT OF THE KIDNEY INJURY. THE PHYSICIAN STATED THAT THEY WERE UNSURE IF THE HEMOLYSIS WAS DUE TO THE IMPELLA RP OR THE IMPELLA CP. IT WAS ALSO REPORTED THE NEXT DAY THAT THE IMPELLA RP BECAME MALPOSITIONED. DUE TO THE MALPOSITION, THE PHYSICIAN DECIDED TO EXPLANT THE PUMP DUE TO THE PATIENT NOT REQUIRING RIGHT VENTRICULAR SUPPORT. THE PATIENT WAS SUCCESSFULLY WEANED AND THE IMPELLA RP WAS EXPLANTED. THE PATIENT REMAINED ON IMPELLA CP SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2601646 IMPELLA RP TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. IMPELLA RP 2024423966 00813502011869

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention