BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24424168 · Received February 23, 2026

    Report

    Report Number
    1220648-2026-03857
    Event Type
    Death
    Date Received
    February 23, 2026
    Date of Event
    February 16, 2026
    Report Date
    March 13, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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

    B1/B2, D6B, AND H6 UPDATED. THE INVESTIGATION IS STILL ONGOING.

    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 E4 (INITIAL REPORTER OCCUPATION). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY SUBMITTED IN ERROR IN THE INITIAL REPORT. CORRECTED INFORMATION WAS PROVIDED IN D3, G1 (MANUFACTURER FAX). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY OMITTED FROM 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 INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Additional Manufacturer Narrative · 0

    B5 UPDATED/CORRECTED. THE INVESTIGATION IS STILL ONGOING.

    Description of Event or Problem · 0

    CLINICIAN NARRATIVE: AN IMPELLA 5.5 WAS INSERTED VIA THE RIGHT AXILLARY ARTERY IN A 66-YEAR-OLD FEMALE WHO PRESENTED WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (SCAI STAGE E). THE PATIENT HAD KNOWN CORONARY ARTERY DISEASE AND REQUIRED INOTROPIC SUPPORT, VASOPRESSOR THERAPY, AND MECHANICAL VENTILATION FOR RESPIRATORY SUPPORT. DURING ICU MONITORING, PREMATURE VENTRICULAR CONTRACTIONS WERE NOTED, INCLUDING 2¿3 BEAT RUNS OF VENTRICULAR TACHYCARDIA. THE PATIENT EXPERIENCED TACHYCARDIA WHILE ON SUPPORT. THE MEDICAL TEAM PLANNED TO EVALUATE SERUM ELECTROLYTES AND REQUESTED ECHOCARDIOGRAPHIC ASSESSMENT TO EVALUATE IMPELLA PUMP POSITION. VENTRICULAR ECTOPY AND TRANSIENT VENTRICULAR TACHYCARDIA ARE RECOGNIZED CLINICAL EVENTS IN PATIENTS WITH ACUTE MYOCARDIAL INFARCTION AND ADVANCED CARDIOGENIC SHOCK. CONTRIBUTING FACTORS MAY INCLUDE MYOCARDIAL ISCHEMIA, ELECTROLYTE IMBALANCE, INOTROPIC THERAPY, VASOPRESSOR USE, AND UNDERLYING STRUCTURAL HEART DISEASE. EVALUATION OF PUMP POSITION AND METABOLIC PARAMETERS IS CONSISTENT WITH STANDARD CLINICAL MANAGEMENT IN THIS SETTING. THE PATIENT SURVIVED.

    Description of Event or Problem · 0

    AN IMPELLA 5.5 WAS INSERTED VIA THE RIGHT AXILLARY ARTERY IN A 66-YEAR-OLD FEMALE WHO PRESENTED WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (SCAI STAGE E). THE PATIENT HAD KNOWN CORONARY ARTERY DISEASE AND REQUIRED INOTROPIC SUPPORT, VASOPRESSOR THERAPY, AND MECHANICAL VENTILATION FOR RESPIRATORY SUPPORT. DURING INTENSIVE CARE UNIT MONITORING, PREMATURE VENTRICULAR CONTRACTIONS WERE NOTED, INCLUDING 2¿3 BEAT RUNS OF VENTRICULAR TACHYCARDIA. THE PATIENT EXPERIENCED TACHYCARDIA WHILE ON SUPPORT. THE MEDICAL TEAM PLANNED TO EVALUATE SERUM ELECTROLYTES AND REQUESTED ECHOCARDIOGRAPHIC ASSESSMENT TO EVALUATE IMPELLA PUMP POSITION. VENTRICULAR ECTOPY AND TRANSIENT VENTRICULAR TACHYCARDIA ARE RECOGNIZED CLINICAL EVENTS IN PATIENTS WITH ACUTE MYOCARDIAL INFARCTION AND ADVANCED CARDIOGENIC SHOCK. CONTRIBUTING FACTORS MAY INCLUDE MYOCARDIAL ISCHEMIA, ELECTROLYTE IMBALANCE, INOTROPIC THERAPY, VASOPRESSOR USE, AND UNDERLYING STRUCTURAL HEART DISEASE. EVALUATION OF PUMP POSITION AND METABOLIC PARAMETERS IS CONSISTENT WITH STANDARD CLINICAL MANAGEMENT IN THIS SETTING. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PATIENT¿S CLINICAL CONDITION CONTINUED TO DECLINE AND THE FAMILY ELECTED TO TRANSITION THE PATIENT TO COMFORT CARE MEASURES. LIFE-SUSTAINING TREATMENTS WERE WITHDRAWN AND THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474182 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026689023 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Death| O