BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24590741 · Received March 13, 2026

    Report

    Report Number
    1220648-2026-05252
    Event Type
    Death
    Date Received
    March 13, 2026
    Date of Event
    March 7, 2026
    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
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    CORRECTED INFORMATION WAS PROVIDED IN D1 (BRAND NAME). UPON REVIEW, IT WAS IDENTIFIED THAT THE SECTION D BRAND NAME HAS NOW BEEN UPDATED. CORRECTED INFORMATION WAS PROVIDED IN D3, G1 (MANUFACTURER FAX). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY OMITTED FROM THE INITIAL REPORT. CORRECTED INFORMATION WAS PROVIDED IN D4 (SERIAL NUMBER). UPON REVIEW, THE SECTION D SERIAL NUMBER HAS NOW BEEN UPDATED. CORRECTED INFORMATION WAS PROVIDED IN E3 (INITIAL REPORTER OCCUPATION). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY SUBMITTED IN ERROR IN THE INITIAL REPORT. H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. THE CAUSE OF THE HIGH PURGE PRESSURE COULD NOT BE DETERMINED AS NO PRODUCT WAS RETURNED TO CONFIRM CAUSE OF REPEATED DROPS AND INCREASES IN PURGE PRESSURE AND LIMITED CLINICAL DETAILS WERE PROVIDED.

    Additional Manufacturer Narrative · 0

    B2 DATE OF DEATH WAS ADDED AS IT WAS OMITTED FROM THE INITIAL REPORT THAT WAS SUBMITTED.

    Description of Event or Problem · 0

    CLINICAL REVIEW/RATIONALE: AN IMPELLA RP FLEX WAS INSERTED VIA THE INTERNAL JUGULAR VEIN TO SUPPORT THE 87 YEAR OLD MALE PATIENT WHO HAD BEEN ADMITTED IN WITH A PULMONARY EMBOLISM, PRESENTING IN SCAI STAGE E SHOCK. THE UNDERLYING MEDICAL HISTORY WAS NOT SHARED. THE RP FLEX WAS PLACED AND THEN THE PATIENT WAS SENT TO THE ICU FOR CONTINUED MONITORING. IN THE ICU THE PUMP HAD HIGH PURGE PRESSURES. THEY ATTEMPTED TO TROUBLESHOOT BY REPLACING THE PURGE CASSETTE, WHICH DID NOT REMEDY THE ISSUE. THE TEAM INSTEAD ADDED THE THROMBOLYTIC TPA TO THE PURGE FLUID. TPA WAS UTILIZED FOR THE HPP TO MITIGATE IMPACT OF BIOMATERIAL WITHIN THE MOTOR AND THERE WAS NO IMPACT ON THE PATIENT. ON THE DAY OF IMPLANT THE PATIENT EXPIRED WHEN THE TEAM AND FAMILY MADE CHOICE TO WITHDRAW CARE. THE DEATH IS CONSERVATIVELY BEING REPORTED ALTHOUGH AN UNLIKELY CONTRIBUTING FACTOR TO THE DEATH, AND MORE LIKELY THE PATIENT'S PRESENTING NATIVE CRITICAL CONDITION AS PRESENTED IN SCAI STAGE E AND PULMONARY EMBOLISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43442 IMPELLA TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. - 1220648 2026741933 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Male Required Intervention| D