BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA RP FLEX

    MDR report key: 23933704 · Received December 31, 2025

    Report

    Report Number
    1220648-2025-49573
    Event Type
    Death
    Date Received
    December 31, 2025
    Date of Event
    September 14, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    PYX
    UDI-DI
    00813502012811
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA PASSED ALL THE POST STERILE INSPECTION CHECKS. THE ROOT CAUSE OF THE CARDIAC FAILUREWAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. THE CAUSE OF RENAL FAILURE AND ORGAN FAILURE WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Additional Manufacturer Narrative · 0

    MEDICAL SAFETY/CLINICAL REVIEWED THE EVENT. THE PATIENT WAS ADMITTED FOR PRESUMED ST ELEVATION MYOCARDIAL INFARCTION; LEFT/RIGHT HEART CATHETERIZATION DEMONSTRATED CLEAN CORONARIES. THE PATIENT EXPERIENCED CARDIAC ARREST AND WAS PLACED ON BIVENTRICULAR MECHANICAL CIRCULATORY SUPPORT, WITH LEFT-SIDED IMPELLA SUPPORT IMPLANTED VIA THE RIGHT FEMORAL ARTERY DURING CARDIOPULMONARY RESUSCITATION, FOLLOWED BY IMPELLA RP FLEX IMPLANTATION VIA THE RIGHT FEMORAL VEIN. RETURN OF SPONTANEOUS CIRCULATION WAS ACHIEVED; HOWEVER, THERE WAS NO VENTRICULAR PULSATILITY. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT ON BIVENTRICULAR SUPPORT WITH MAXIMAL VASOPRESSOR AND INOTROPIC THERAPY. THE PATIENT REMAINED IN REFRACTORY SHOCK WITH ANURIA, NO NEUROLOGICAL RESPONSE, RENAL FAILURE, AND PROGRESSIVE MULTISYSTEM ORGAN FAILURE ALL KNOWN FACTORS OF PATIENTS IN CARDIOGENIC SHOCK. AFTER DISCUSSION WITH THE FAMILY, FURTHER ESCALATION OF CARE WAS DEFERRED, CARE WAS WITHDRAWN, AND THE PATIENT EXPIRED. CONSERVATIVELY, THE DEATH WILL BE REPORTED ON BOTH IMPELLA DEVICES AS THE IMPELLA DEVICES WERE IN USE AT TIME OF EXPIRATION. NOTE: H6: DEVICE PROBLEM/COMPONENT/INVESTIGATION CODING REMAINS UNCHANGED. RELATED MEDICAL DEVICE REPORTS: THIS IS ONE OF TWO DEVICES ASSOCIATED WITH THE EVENT. REFER TO THE RELATED MANUFACTURER REPORT NUMBER(S) AS NOTED IN SECTION H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN IMPELLA RP FLEX LOST PULSATILITY IN THE RIGHT AND LEFT VENTRICLES. THE PATIENT WENT INTO RENAL FAILURE AND END ORGAN FAILURE WITH DIFFUSE SHOCK. CARE WAS WITHDRAWN AND THE PATIENT ULTIMATELY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2462443 IMPELLA RP FLEX TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. IMPELLA RP FLEX 2025487237 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Death