BEUDAMED
    FDA Adverse Event Death Summary report: N

    RP FLEX W SMART ASSIST SET, US

    MDR report key: 24141563 · Received January 21, 2026

    Report

    Report Number
    1220648-2026-01291
    Event Type
    Death
    Date Received
    January 21, 2026
    Date of Event
    January 6, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    PYX
    UDI-DI
    813502012811
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. INVESTIGATION SUMMARY: HEMODYNAMIC INSTABILITY/PERI-PROCEDURAL ADVERSE EVENT: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    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

    CLINICAL NARRATIVE; IMPELLA RP FLEX SUPPORT WAS INITIATED VIA FEMORAL ACCESS IN A 54-YEAR-OLD MALE WHO PRESENTED WITH RIGHT HEART FAILURE IN THE SETTING OF PULMONARY EMBOLISM. THE PATIENT REQUIRED ADVANCED HEMODYNAMIC AND RESPIRATORY SUPPORT, INCLUDING INOTROPIC THERAPY, VASOPRESSORS, AND MECHANICAL VENTILATION. THROMBECTOMY WAS PERFORMED. UNSUCCESSFUL EVACUATION OF RIGHT PA THROMBUS. RP FLEX IS INSERTED WITHOUT ISSUE, BUT PATIENT OXYGENATION NEVER IMPROVED DESPITE RV SUPPORT. THE IMPELLA RP FLEX WILL BE CODED FOR HEMODYNAMIC INSTABILITY BASED ON THE PATIENT¿S CLINICAL COURSE AND WILL ALSO BE REPORTED FOR DEATH; HOWEVER, THE DEATH IS CONSERVATIVELY CODED GIVEN THE PATIENT¿S SEVERE UNDERLYING CONDITION. THE REPORTED EVENT IS REASONABLY ATTRIBUTED TO THE SEVERITY OF THE UNDERLYING DISEASE PROCESS AND ASSOCIATED CLINICAL DETERIORATION OF THE PATIENT. THEREFORE, NO CAUSAL RELATIONSHIP BETWEEN THE IMPELLA RP FLEX AND THE PATIENT¿S DEATH WAS ESTABLISHED. PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188920 RP FLEX W SMART ASSIST SET, US TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. - 1220648 2025502625 813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Death