BEUDAMED
    FDA Adverse Event Death Summary report: N

    RP FLEX W SMART ASSIST SET, US

    MDR report key: 24345345 · Received February 16, 2026

    Report

    Report Number
    1220648-2026-03264
    Event Type
    Death
    Date Received
    February 16, 2026
    Date of Event
    September 26, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    PYX
    UDI-DI
    00813502012811
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED IN B5 (EVENT DESCRIPTION) AND B7 (MEDICAL HISTORY/PREEXISTING CONDITION). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY OMITTED IN ERROR IN THE INITIAL REPORT. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ABIOMED INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ABIOMED INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    THE EXACT DATE OF DEATH IS UNKNOWN BUT HAS BEEN CAPTURED AS THE DATE OF EXPLANT. IF ACTUAL INFORMATION BECOMES KNOWN, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE STATUS. THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER; THEREFORE, AN 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 PATIENT SUFFERED CARDIAC ARREST DURING PHYSICAL THERAPY AND ACHIEVED RETURN OF SPONTANEOUS CIRCULATION (ROSC) AFTER RESUSCITATION. UPON ARRIVAL AT THE EMERGENCY DEPARTMENT, THE PATIENT EXPERIENCED A SECOND CARDIAC ARREST AND WAS AGAIN RESUSCITATED WITH ROSC. DIAGNOSTIC EVALUATION REVEALED BILATERAL PULMONARY EMBOLISMS, AND THE PATIENT UNDERWENT THROMBECTOMY. DESPITE INTERVENTION, THE PATIENT REMAINED IN SCAI STAGE E CARDIOGENIC SHOCK. AN IMPELLA RP FLEX DEVICE WAS PLACED FOR RIGHT-SIDED MECHANICAL CIRCULATORY SUPPORT, OFF-LABEL USE FOR PATIENT WITH PULMONARY EMBOLISM DUE TO THE RISK OF CLOT INGESTION. THE PATIENT WAS SUPPORTED FOR APPROXIMATELY 10.9 HOURS. PLACEMENT SIGNAL NOT RELIABLE ALARM WAS NOTED BUT DID NOT IMPACT PATIENT SUPPORT. A DECISION WAS MADE TO WITHDRAW CARE DUE TO CLINICAL DETERIORATION, AND THE RP FLEX WAS EXPLANTED. THE PATIENT EXPIRED FOLLOWING RP FLEX REMOVAL. THE DEATH WILL BE CONSERVATIVELY REPORTED TO THE RP FLEX DEVICE BUT WAS MOST LIKELY DUE TO THE UNDERLYING CRITICAL CLINICAL CONDITION OF THE PATIENT DUE TO PRIOR MULTIPLE CARDIAC ARRESTS.

    Description of Event or Problem · 0

    INTERMITTENT PSNR ALARM WITH ABSENT PLACEMENT SIGNALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466033 RP FLEX W SMART ASSIST SET, US TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. 2025483300 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1