BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24579384 · Received March 12, 2026

    Report

    Report Number
    1220648-2026-05147
    Event Type
    Death
    Date Received
    March 12, 2026
    Date of Event
    March 6, 2026
    Report Date
    March 12, 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
    IA, 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 D1. THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    CLINICIAN NARRATIVE: AN IMPELLA CP WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN A 67-YEAR-OLD MALE FOR HEMODYNAMIC SUPPORT IN THE SETTING OF NON-ISCHEMIC CARDIOMYOPATHY WITH CARDIOGENIC SHOCK SCAI STAGE D. PRIOR TO DEVICE INSERTION, THE PATIENT¿S LEFT VENTRICULAR EJECTION FRACTION WAS REPORTED AS 5%, INDICATING SEVERE VENTRICULAR DYSFUNCTION. THE PATIENT REQUIRED INOTROPIC SUPPORT, VASOPRESSOR THERAPY, AND MECHANICAL VENTILATION FOR RESPIRATORY SUPPORT. THE STARTING LACTATE WAS 2.3 MMOL/L, REFLECTING SYSTEMIC HYPOPERFUSION. THE DEVICE PURGE SOLUTION CONSISTED OF D5W, AND THE PUMP WAS INITIATED TO PROVIDE CIRCULATORY SUPPORT. DURING SUPPORT, THE PATIENT DEVELOPED NEW PINK-TINGED URINE, CONSISTENT WITH HEMATURIA. THE REPORTED PATIENT EXPERIENCE WAS RELATED TO THE PUMP AND HEMATURIA WHILE THE PATIENT REMAINED CRITICALLY ILL WITH ADVANCED CARDIOGENIC SHOCK AND SEVERE UNDERLYING CARDIOMYOPATHY. HEMATURIA MAY OCCUR IN CRITICALLY ILL PATIENTS REQUIRING MECHANICAL CIRCULATORY SUPPORT AND CAN BE INFLUENCED BY MULTIPLE CLINICAL FACTORS INCLUDING HEMOLYSIS, ANTICOAGULATION THERAPY, HEMODYNAMIC INSTABILITY, AND THE PATIENT¿S OVERALL CRITICAL CONDITION. SUBSEQUENTLY, CARE WAS WITHDRAWN BY THE TREATING TEAM AND FAMILY, AND THE PATIENT EXPIRED. BASED ON THE AVAILABLE INFORMATION, THE PATIENT OUTCOME OCCURRED IN THE CONTEXT OF ADVANCED CARDIOGENIC SHOCK AND SEVERE UNDERLYING CARDIAC DISEASE REQUIRING MAXIMAL SUPPORTIVE THERAPIES. A COMPREHENSIVE REVIEW OF THE AVAILABLE INFORMATION DID NOT IDENTIFY EVIDENCE SUGGESTING THE DEVICE CONTRIBUTED TO THE REPORTED OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639969 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027835221 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Death