BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 25014964 · Received April 28, 2026

    Report

    Report Number
    1220648-2026-07166
    Event Type
    Death
    Date Received
    April 28, 2026
    Date of Event
    April 24, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    PYX
    UDI-DI
    00813502012811
    PMA / PMN Number
    P170011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A4 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

    B2. IS DEATH AND DATE OF DEATH ADDED. B5. ADDITIONAL EVENT DESCRIPTION ADDED. D4. CATALOG AND SERIAL CORRECTED. D6B. EXPLANTATION DAY, MONTH AND YEAR ADDED. H1. TYPE OF REPORTABLE EVENT UPDATED. H6. HEALTH EFFECT - IMPACT CODES ADDED. H6. MEDICAL DEVICE PROBLEM CODE ADDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN IMPLELLA RP FLEX EXPERIENCED A PLACEMENT SIGNAL NOT RELIABLE ALARM. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM CLINICAL NARRATIVE REPORTING AN IMPELLA RP FLEX DEVICE WAS INSERTED VIA THE RIGHT FEMORAL VEIN IN A 64-YEAR-OLD FEMALE PATIENT PRESENTING WITH POSTCARDIOTOMY CARDIOGENIC SHOCK/LOW CARDIAC OUTPUT SYNDROME (PCCS/LCOS). THE PATIENT¿S COMORBIDITIES WERE UNKNOWN. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS IDENTIFIED AS SCAI SHOCK STAGE E. DURING SUPPORT, A PLACEMENT SIGNAL NOT RELIABLE ALARM WAS PRESENT. THE CATHETER DID NOT ZERO PROPERLY, BUT THE PHYSICIAN DID NOT WANT TO WAIT FOR A NEW CATHETER TO PRIME. AFTER INSERTION AND ACTIVATION AT P2, THE CATHETER WAS MANUALLY ZEROED, AT WHICH TIME THE PLACEMENT SIGNAL NOT RELIABLE ALARM APPEARED. A HIGH PURGE PRESSURE ALARM WAS NOTED, WITH NO KINKS FOUND. THE PATIENT HAD NOT BEEN ON HEPARIN. TISSUE PLASMINOGEN ACTIVATOR (TPA) SOLUTION WAS CONNECTED TO THE PURGE LINE. AFTER A FEW HOURS, THE PURGE PRESSURE ALARM STOPPED PER THE RN. TPA WAS UTILIZED FOR THE HIGH PURGE PRESSURE TO MITIGATE THE IMPACT OF BIOMATERIAL WITHIN THE MOTOR; THIS IS AN OFF-LABEL USE AND THERE WAS NO IMPACT ON THE PATIENT. THE PATIENT EXPIRED ON SUPPORT. THE DEVICE WILL BE CONSERVATIVELY REPORTED FOR DEATH; HOWEVER, THE DEATH IS MOST LIKELY ATTRIBUTED TO THE PATIENT'S UNDERLYING CRITICAL CLINICAL CONDITION AS THEY PRESENTED IN SCAI SHOCK STAGE E.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565562 IMPELLA TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. - 1220648 2026764789 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Death