BEUDAMED
    FDA Adverse Event Death Summary report: N

    RP FLEX W SMART ASSIST SET, US

    MDR report key: 24193242 · Received January 27, 2026

    Report

    Report Number
    1220648-2026-01637
    Event Type
    Death
    Date Received
    January 27, 2026
    Date of Event
    January 19, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    PYX
    UDI-DI
    813502012811
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: ADDED CODE A0709 BASED ON A REVIEW OF THE INFORMATION IN THE COMPLAINT FILE. H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. INVESTIGATION SUMMARY - THROMBOSIS: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. LOW OR BLOCKED PUMP FLOW: THE CAUSE OF THE LOW PUMP FLOW WAS NOT DETERMINED DUE TO NO PRODUCT OR DATA LOGS RETURNED FOR ANALYSIS. PLACEMENT SIGNAL ISSUE: THE CAUSE OF THE PLACEMENT SIGNAL ISSUE WAS NOT DETERMINED DUE TO NO PRODUCT OR DATA LOGS RETURNED FOR ANALYSIS.

    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 RATIONALE: A 61-YEAR-OLD FEMALE UNDERGOING SUPPORT FOR ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK WAS TREATED WITH TWO IMPELLA PUMPS (CP AND RP) PLACED PERCUTANEOUSLY VIA THE LEFT FEMORAL ARTERY AND RIGHT FEMORAL VEIN, RESPECTIVELY. DURING SUPPORT WITH THE RP SYSTEM, A POSSIBLE CLOT INGESTION EVENT WAS REPORTED IN THE RIGHT PUMP, COINCIDING WITH A SUDDEN RISE IN PULMONARY ARTERY PRESSURES TO THE 100S (MAPS INCREASING FROM THE 40S MAP) AND PUMP FLOWS DROPPING TO 0.0 L/MIN AT P6 WITH SUCTION NOTED ON THE CP SIDE. PUMP 1. PUMP 1 (CP; SN (B)(6)) WAS IMPLANTED ON (B)(6) 2026 AT 20:53 AND EXPLANTED ON (B)(6) 2026 AT 15:08, WITH THE PATIENT EXPIRING AT THE TIME OF EXPLANT. PUMP 2 (RP FLEX; SN (B)(6)) WAS IMPLANTED ON (B)(6) 2026 AT 00:02 AND EXPLANTED ON (B)(6) 2026 AT 15:10, WITH EXPIRATION OCCURRING AT THE TIME OF EXPLANT. REPORTED FAILURE MODES INCLUDED LOW OR BLOCKED PUMP FLOW FOR PUMP 1 AND THROMBOSIS AND DEATH FOR PUMP 2. BASED ON THE AVAILABLE INFORMATION, THE EVENT INVOLVED LOW PUMP FLOW AND SUSPECTED THROMBUS INTERACTION WITH THE RP DEVICE; HOWEVER, THE EXACT CAUSE OF PUMP PERFORMANCE ISSUES AND PATIENT¿S DEATH CANNOT BE DETERMINED AT THIS TIME DUE TO MULTIPLE UNKNOWN CLINICAL AND PROCEDURAL FACTORS. THE DEATH IS CONSERVATIVELY BEING REPORTED TO THE IMPELLA RP FLEX BUT IS UNLIKELY A CONTRIBUTING FACTOR AND IS MOST LIKELY ATTRIBUTED TO PATIENTS UNDERLYING CRITICAL CONDITION. THE PATIENT PRESENTED IN SCAI STAGE E IN A STATE OF RAPID COLLAPSE OR CARDIAC ARREST REQUIRING MAXIMAL INTERVENTION WITH MULTIPLE VASOPRESSORS AND SEVERE HYPOPERFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250184 RP FLEX W SMART ASSIST SET, US TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. - 1220648 2025477204 813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Death