BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24466174 · Received February 27, 2026

    Report

    Report Number
    1220648-2026-04184
    Event Type
    Death
    Date Received
    February 27, 2026
    Date of Event
    September 22, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    PYX
    UDI-DI
    00813502012811
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5. UPDATED EVENT DESCRIPTION ADDED. D1. BRAND NAME UPDATED. H6. HEALTH EFFECT - CLINICAL CODE, E050304 ADDED. H6. MEDICAL DEVICE PROBLEM CODE, PURGE PRESSURE HIGH AND DEVICE REVISION OR REPLACEMENT, REMOVED.

    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.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION HAS BEEN PROVIDED IN D4 (SERIAL). THROMBOEMBOLISM: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. PUMP DID NOT START: THE ROOT CAUSE OF THE PUMP DID NOT START WAS MOST LIKELY BIOMATERIAL INGESTION BASED ON THE PROVIDED CLINICAL DETAILS AND DATA LOG ANALYSIS.

    Description of Event or Problem · 0

    ADDITIONAL CLINICAL REVIEW REPORTS A 71-YEAR-OLD MALE PATIENT WITH POSTCARDIOTOMY CARDIOGENIC SHOCK (PCCS), PRE-SUPPORT CLINICAL CONDITION CONSISTENT WITH SCAI SHOCK STAGE E, REQUIRED IMPELLA RP FLEX SUPPORT. DURING SUPPORT, THE INITIALLY PLACED RP FLEX DEVICE, INSERTED VIA FEMORAL ACCESS, WAS PRESUMED TO HAVE CLOTTED, PROMPTING PLACEMENT OF A SECOND RP FLEX DEVICE VIA THE INTERNAL JUGULAR APPROACH. UPON ACTIVATION, THE SECOND DEVICE STOPPED FUNCTIONING WITHIN SECONDS, WITH WAVEFORM APPEARANCE SUGGESTIVE OF ACUTE THROMBOSIS, POTENTIALLY RELATED TO THROMBUS PRESENT ON THE FIRST DEVICE. THE FIRST PUMP WAS PARTIALLY WITHDRAWN INTO THE INFERIOR VENA CAVA; HOWEVER, COMPLETE DEVICE REMOVAL WAS NOT FEASIBLE AS THE PATIENT WAS CRITICALLY DEPENDENT ON MECHANICAL CIRCULATORY SUPPORT AND HAD MULTIPLE INDWELLING LINES THAT COULD NOT BE SAFELY REMOVED. ANTICOAGULATION TARGETS (ACT) WERE NOT MAINTAINED THROUGHOUT SUPPORT. DESPITE MAXIMAL SUPPORTIVE MEASURES, THE PATIENT EXPIRED WHILE ON SUPPORT. THE PATIENT HAD SEVERE RIGHT VENTRICULAR FAILURE AND END-ORGAN FAILURE PRIOR TO DEVICE IMPLANTATION. BASED ON THE AVAILABLE INFORMATION, THE PATIENT DEATH WAS NOT ATTRIBUTED TO THE IMPELLA RP FLEX DEVICE. THE PATIENT PRESENTED WITH PROFOUND, PRE-EXISTING RIGHT VENTRICULAR FAILURE AND CRITICAL CARDIOGENIC SHOCK REQUIRING MAXIMAL SUPPORT. WHILE SUSPECTED DEVICE THROMBOSIS OCCURRED AND LIMITED THE ABILITY OF THE SYSTEM TO PROVIDE CONTINUED CIRCULATORY SUPPORT, THE OUTCOME WAS ATTRIBUTED TO THE SEVERITY OF THE PATIENT¿S UNDERLYING CONDITION RATHER THAN DEVICE-RELATED INJURY OR MALFUNCTION. THE DEATH IS CONSERVATIVELY BEING REPORTED TO THE IMPELLA RP FLEX BUT IS UNLIKELY RELATED AND IS MOST LIKELY ATTRIBUTED TO PATIENTS UNDERLYING CRITICAL CONDITION AS THEY PRESENTED IN SCAI STAGE E SHOCK ON MULTIPLE INOTROPES AND PRESSORS AND WAS VENTILATED FOR RESPIRATORY SUPPORT.

    Description of Event or Problem · 0

    A 71-YEAR-OLD MALE WITH CORONARY ARTERY DISEASE SUFFERED A STEMI COMPLICATED BY VENTRICULAR SEPTAL RUPTURE. HE UNDERWENT CABG WITH VSR REPAIR AND SUBSEQUENTLY DEVELOPED POST-CARDIOTOMY SHOCK. AN IABP WAS PLACED AND LATER REPOSITIONED DUE TO LIMB ISCHEMIA. ON POD1, AN IMPELLA RP FLEX WAS IMPLANTED FOR RIGHT-SIDED CIRCULATORY SUPPORT. AT P-9, FLOW WAS 3.8 L/MIN WITH ADEQUATE HEMODYNAMICS. THE PATIENT REQUIRED MECHANICAL VENTILATION, VASOACTIVE DRUGS, CRRT, AND SYSTEMIC HEPARIN. ON POD7, THE PATIENT TOLERATED IABP WEANING BUT DID NOT TOLERATE REDUCTION OF THE IMPELLA RP FLEX TO P-2 BY TEE, SO SUPPORT CONTINUED. LATER THAT DAY, THE AIC DISPLAYED A ¿PURGE SYSTEM BLOCKED¿ ALARM ACCOMPANIED BY HYPOTENSION. PER TREATING PHYSICIAN, TENECTEPLASE WAS ADMINISTERED VIA THE PURGE LINE, RESULTING IN IMPROVED PURGE FLOW AND REDUCED PURGE PRESSURE WITH ALARM RESOLUTION. THE CLINICAL TEAM DECIDED TO REPLACE THE IMPELLA RP FLEX. THE PATIENT EXPIRED SHORTLY AFTER DEVICE REPLACEMENT. DEVICE RETURN AND EVALUATION ARE PENDING. THIS REPORT IS SUBMITTED DUE TO PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532595 IMPELLA TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. - 1220648 2025575894 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1