BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24764702 · Received April 2, 2026

    Report

    Report Number
    1220648-2026-06277
    Event Type
    Death
    Date Received
    April 2, 2026
    Date of Event
    March 29, 2026
    Report Date
    April 2, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST
    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

    B1 PRODUCT PROBLEM AND E4 WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT.

    Additional Manufacturer Narrative · 0

    UPON REVIEW, IT WAS IDENTIFIED THAT THE MANUFACTURER FAX (D3) WAS INADVERTENTLY OMITTED IN ERROR; THE COMPLETE FAX NUMBER HAS NOW BEEN PROVIDED. CORRECTED INFORMATION HAS BEEN PROVIDED IN D4 SERIAL NUMBER. E4 REPORTER ALSO SENT REPORT TO FDA WAS INADVERTENTLY OMITTED IN ERROR FROM INITIAL AND HAS NOW BEEN PROVIDED. H6 INVESTIGATION: TYPE, FINDINGS, AND CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. THE CAUSE OF HEMOLYSIS/MECHANICAL INTERACTION WITH BLOOD WAS UNABLE TO BE DETERMINED AS LIMITED CLINICAL DETAILS WERE PROVIDED AND NO PRODUCT WAS RETURNED FOR REVIEW. THE CAUSE OF LOW OR BLOCKED PUMP FLOW WAS UNABLE TO BE DETERMINED AS LIMITED CLINICAL DETAILS WERE PROVIDED AND NO PRODUCT WAS RETURNED FOR REVIEW.

    Description of Event or Problem · 0

    AN IMPELLA CP DEVICE WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN A 74-YEAR-OLD FEMALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS), SCAI SHOCK STAGE E, WITH A HISTORY OF KNOWN DIABETES MELLITUS. DURING SUPPORT, HEMOLYSIS WAS SUSPECTED. THE REGISTERED NURSE REPORTED CONCERN FROM THE CARE TEAM DUE TO DARK RED URINE AND LABORATORY SAMPLES THAT WERE CONSISTENTLY HEMOLYZED FOLLOWING A SUCTION ALARM. HEMODYNAMIC PARAMETERS PROVIDED INCLUDED A CENTRAL VENOUS PRESSURE (CVP) OF 15 AND A PULMONARY ARTERY PULSATILITY INDEX (PAPI) OF 2. DEVICE POSITION WAS VERIFIED BY ECHOCARDIOGRAPHY. AN ORDER WAS PLACED TO DECREASE IMPELLA FLOWS TO PERFORMANCE LEVEL P-6. THE CARE TEAM DISCUSSED INITIATION OF DIALYSIS. CARE WAS SUBSEQUENTLY WITHDRAWN, AND THE PATIENT EXPIRED. THE REPORTED HEMOLYSIS MAY OCCUR IN THE SETTING OF PURGE-RELATED ANTICOAGULATION REQUIREMENTS AND MAY BE INFLUENCED BY UNDERLYING SEVERE CARDIOGENIC SHOCK, LOW-FLOW PHYSIOLOGY, HEMODYNAMIC INSTABILITY, RENAL DYSFUNCTION, AND POTENTIAL DEVICE-POSITION¿RELATED FACTORS. THE REPORTED RENAL FAILURE IS CONSISTENT WITH MULTIORGAN DYSFUNCTION ASSOCIATED WITH PROLONGED AMI/CGS, HEMODYNAMIC COMPROMISE, AND HEMOLYSIS, CONTRIBUTING TO THE CLINICAL DECISION TO CONSIDER RENAL REPLACEMENT THERAPY. THE DEVICE WILL BE CONSERVATIVELY REPORTED FOR DEATH; HOWEVER, THE DEATH IS MOST LIKELY ATTRIBUTABLE TO THE SEVERITY OF THE UNDERLYING AMI/CGS AS THEY PRESENTED IN SCAI STAGE E.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608887 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027845377 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1