BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24557148 · Received March 10, 2026

    Report

    Report Number
    1220648-2026-04866
    Event Type
    Death
    Date Received
    March 10, 2026
    Date of Event
    February 26, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    PYX
    UDI-DI
    00813502012811
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A5 IS UNKNOWN. 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

    D4 REVISED.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION HAS BEEN PROVIDED IN D1. PULMONARY EDEMA/CARDIAC ARREST: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. PLACEMENT SIGNAL ISSUE: THE CAUSE OF THE ISSUE WAS TRACED TO ANOTHER DEVICE AS EVIDENCED BY CLINICAL INFORMATION CAUSING SOURCE OF DAMAGE AND LOG ANALYSIS CONFIRMING LOSS OF PARAMETERS DUE TO INTERACTION. PRODUCT DAMAGE: THE CAUSE OF THE ISSUE WAS TRACED TO ANOTHER DEVICE AS EVIDENCED BY CLINICAL INFORMATION CAUSING SOURCE OF DAMAGE.

    Description of Event or Problem · 0

    AN IMPELLA RP FLEX WAS INSERTED VIA RIGHT INTERNAL JUGULAR VEIN AND AN IMPELLA CP INSERTED VIA RIGHT FEMORAL ARTERY FOR BIPELLA SUPPORT POST CARDIOTHORACIC SURGERY IN A 76 YEAR OLD FEMALE. THE PATIENT¿S COMORBIDITIES WERE UNKNOWN. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS SCAI STAGE D. DURING THE PROCEDURE, THE RP FLEX OPTICAL SENSOR WAS DAMAGED WHEN PUSHING THE DEVICE ACROSS THE TRICUSPID RING. THERE WERE NO METRICS FROM THE PUMP, HOWEVER THE PUMP WAS ABLE TO BE USED USING THE P LEVEL FLOW GUIDE. ALSO DURING THE PROCEDURE, THE PATIENT DEVELOPED FLASH PULMONARY EDEMA AFTER THE FLOW WAS INCREASED ON THE RP FLEX. THE PATIENT ARRESTED AND REQUIRED CARDIOPULMONARY RESUSCITATION. ON DAY 2 OF SUPPORT, WHILE IN THE INTENSIVE CARE UNIT, OOZING WAS NOTICED FROM THE CP RIGHT GROIN SITE AND 2 UNITS OF BLOOD TRANSFUSED. CARE WAS WITHDRAWN AND THE PATIENT EXPIRED. THE REPORTED EVENTS INCLUDE PRODUCT DAMAGE, SENSING ISSUE, PULMONARY EDEMA, CARDIAC ARREST AND DEATH. THE REPORTED PULMONARY EDEMA AND CARDIAC ARREST ARE MORE PLAUSIBLY ATTRIBUTED TO THE PATIENT¿S UNDERLYING CRITICAL CONDITION. THE DEATH WILL BE CONSERVATIVELY REPORTED TO THE IMPELLA RP FLEX; HOWEVER, THE DEVICE IS UNLIKELY TO HAVE CONTRIBUTED TO THE PATIENT¿S DEATH, WHICH WAS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CRITICAL CLINICAL CONDITION AS THEY PRESENTED WITH SCAI SHOCK STAGE D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615038 IMPELLA TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. - 1220648 2026772347 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Death