BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24456285 · Received February 26, 2026

    Report

    Report Number
    1220648-2026-04119
    Event Type
    Injury
    Date Received
    February 26, 2026
    Date of Event
    February 19, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    PYX
    UDI-DI
    00813502012811
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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

    CORRECTED INFORMATION HAS BEEN PROVIDED IN D1 BRAND NAME. H6 INVESTIGATION: TYPE, FINDINGS, AND CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE CAUSE OF THE HEMOLYSIS CANNOT BE DETERMINED SINCE NO PRODUCT OR DATA LOGS WERE RETURNED AND INSUFFICIENT CLINICAL DETAILS WERE PROVIDED.

    Description of Event or Problem · 0

    CLINICAL RATIONALE: AN IMPELLA RP FLEX WAS INSERTED VIA THE RIGHT INTERNAL JUGULAR VEIN IN A 75-YEAR-OLD FEMALE PATIENT WITH CARDIOMYOPATHY, PRESENTING IN SCAI STAGE D SHOCK. DEVICE INSERTION AND POSITIONING WERE INITIALLY REPORTED AS UNEVENTFUL, WITH PLACEMENT VERIFIED IN THE CVL AND AGAIN ON ARRIVAL TO THE ICU. DURING SUPPORT, THE PATIENT DEVELOPED HEMOLYSIS, EVIDENCED BY TINGED URINE AND A DROP IN HEMOGLOBIN FROM 7.8 G/DL AT THE START OF THE PROCEDURE TO 5.1 G/DL IN THE ICU, PROMPTING TRANSFUSION OF 2 UNITS OF PRBCS. IMAGING WAS USED TO CONFIRM APPROPRIATE PUMP POSITION DURING THE HEMOLYSIS EPISODE, AND ACT WAS MAINTAINED AT TARGET LEVELS. THE PATIENT HAD A SIGNIFICANTLY ELEVATED INR OF 6.1 PRIOR TO INITIATION OF SUPPORT AND A COMPLEX RECENT MEDICAL HISTORY, INCLUDING PACER LEAD EXTRACTION WITH GENERATOR REPLACEMENT AND MULTIPLE PRIOR CENTRAL VENOUS LINES. THE DEVICE WAS NOT REMOVED DUE TO THE EVENT BUT WAS LATER REMOVED PER PHYSICIAN DIRECTION; HOWEVER, THE PUMP WAS DISCARDED AND UNAVAILABLE FOR EVALUATION. BASED ON THE AVAILABLE INFORMATION, THE HEMOLYSIS APPEARS CLINICALLY ASSOCIATED WITH IMPELLA RP FLEX SUPPORT AND THE PATIENT¿S ANTICOAGULATION STATUS RATHER THAN EVIDENCE OF DEVICE MALFUNCTION. HEMOLYSIS IS A KNOWN RISK ASSOCIATED WITH THE IMPELLA RP FLEX PER THE INSTRUCTIONS FOR USE (IFU).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524407 IMPELLA TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. - 1220648 2025546000 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention