BEUDAMED
    FDA Adverse Event Death Summary report: N

    RP FLEX W SMART ASSIST SET, US

    MDR report key: 24196704 · Received January 27, 2026

    Report

    Report Number
    1220648-2026-01652
    Event Type
    Death
    Date Received
    January 27, 2026
    Date of Event
    December 16, 2025
    Report Date
    January 27, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    PYX
    UDI-DI
    813502012811
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL SAFETY/CLINICAL REVIEWED THE EVENT. THE PATIENT WAS ON BIPELLA SUPPORT. THE 1ST IMPELLA CP HAD A POSITIONING / LOW FLOW ISSUE A COUPLE DAYS INTO SUPPORT AND IT WAS REPLACED. BIPELLA SUPPORT CONTINUED. TWO DAYS LATER, THE PATIENT HAD PRESUMED HEPARIN-INDUCED THROMBOCYTOPENIA (HIT) ATTRIBUTED TO THE RP FLEX. HOWEVER, BEFORE THE TEST RESULTS COULD CONFIRM, CARE WAS WITHDRAWN AND THE PATIENT THEN PASSED AWAY. THE DECISION TO WITHDRAW CARE WAS NOT ATTRIBUTED TO THE HIT. IN THIS CASE THE PATIENT'S UNDERLYING CONDITION CONTRIBUTED MOST TO THE DEMISE OUTCOME. NOTE: H6 INVESTIGATION TYPE/FINDINGS/CONCLUSION REMAINS UNCHANGED. RELATED MEDICAL DEVICE REPORTS: THIS IS ONE OF THREE DEVICES ASSOCIATED WITH THE EVENT. REFER TO THE RELATED MANUFACTURER REPORT NUMBER(S) AS NOTED IN SECTION H10.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS COMPLETED AND NO DEVICE WAS RETURNED. INVESTIGATION SUMMARY: PPAE: (THROMBOCYTOPENIA): THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY REVIEW WAS COMPLETED AND PASSED ALL THE POST STERILE INSPECTION CHECKS.

    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 MDR WILL BE FILED.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT THE PATIENT WAS PRESUMED TO BE HEPARIN-INDUCED THROMBOCYTOPENIA (HIT) POSITIVE AND WAS TRANSITIONED TO ARGATROBAN. A DECISION TO WITHDRAW CARE WAS MADE BEFORE CONFIRMATORY TESTING COULD BE COMPLETED. THE DECISION TO WITHDRAW CARE WAS NOT ATTRIBUTED TO THE POTENTIAL DIAGNOSIS OF HIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257932 RP FLEX W SMART ASSIST SET, US TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. - 1220648 RP FLEX W SMART ASSIST SET, US 2025461497 813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Death