BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 25135192 · Received May 11, 2026

    Report

    Report Number
    1220648-2026-07713
    Event Type
    Death
    Date Received
    May 11, 2026
    Date of Event
    May 6, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    PYX
    UDI-DI
    00813502012811
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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

    H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION AND ADDED CLINICAL REVIEW. CORRECTED INFORMATION HAS BEEN PROVIDED IN D3 (MANUFACTURER FAX). UPON REVIEW, IT WAS IDENTIFIED THAT THE INFORMATION WAS INADVERTENTLY NOT SUBMITTED IN THE INITIAL REPORT. THE ROOT CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: A 72-YEAR-OLD MALE WITH AN INDICATION FOR USE OF PULMONARY EMBOLISM AND A PRE-SUPPORT CLINICAL STATE CONSISTENT WITH SCAI SHOCK STAGE E UNDERWENT IMPELLA CP SUPPORT VIA RIGHT FEMORAL VENOUS, PERCUTANEOUS ACCESS ON (B)(6) 2026 AT 15:30. DURING A PULMONARY EMBOLISM THROMBECTOMY, THE PATIENT CODED THREE TO FOUR TIMES AND RECEIVED HEPARIN AND TISSUE PLASMINOGEN ACTIVATOR (TPA) AS PART OF THE PROCEDURE. POST-PROCEDURALLY, NURSING STAFF REPORTED THE PATIENT REQUIRED TRANSFUSION OF TWO UNITS OF BLOOD OVERNIGHT DUE TO A HEMOGLOBIN LEVEL OF 6 G/DL. THE PATIENT HAD END-ORGAN FAILURE AT CASE START AND OTHER CONTRIBUTING FACTORS INCLUDED MASSIVE PULMONARY EMBOLISM, SYSTEMIC ANTICOAGULATION, AND MULTIPLE EPISODES OF CARDIOPULMONARY RESUSCITATION. TARGET ACT WAS MAINTAINED THROUGHOUT SUPPORT, AND THERE WAS NO ACTIVE INFECTION AT CASE START. THERE WAS NO KNOWN HISTORY OF MURAL THROMBUS OF THE RIGHT ATRIUM OR VENA CAVA, AND ISSUE ONSET DID NOT COINCIDE WITH LINE MANIPULATION, ECMO DECANNULATION, OR DEVICE REPOSITIONING. SHORTLY THEREAFTER, THE PATIENT¿S CARE WAS WITHDRAWN, AND THE PATIENT EXPIRED. THE DEVICE WAS LEFT IN SITU AND THE PATIENT WAS SENT TO THE CORONER, RENDERING THE PRODUCT UNAVAILABLE FOR RETURN. BASED ON THE AVAILABLE INFORMATION, THIS EVENT REPRESENTS A PATIENT DEATH FOLLOWING WITHDRAWAL OF CARE. THE DEATH IS CONSERVATIVELY BEING REPORTED TO THE IMPELLA RP FLEX BUT IS UNLIKELY RELATED AND IS MOST LIKELY ATTRIBUTED TO PATIENT¿S PULMONARY EMBOLISM, END ORGAN FAILURE, UNDERLYING CRITICAL CONDITION AS THEY PRESENTED IN SCAI STAGE E SHOCK ON MULTIPLE INOTROPES AND PRESSORS AND WAS VENTILATED FOR RESPIRATORY SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220069 IMPELLA TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. - 1220648 2026815664 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1