BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24777522 · Received April 3, 2026

    Report

    Report Number
    1220648-2026-06361
    Event Type
    Injury
    Date Received
    April 3, 2026
    Date of Event
    March 27, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    PYX
    UDI-DI
    00813502012811
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS DISCARDED. 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. THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA RP FLEX WAS INSERTED VIA THE FEMORAL VEIN TO SUPPORT THE 71 YEAR OLD FEMALE PATIENT WHO HAD BEEN ADMITTED IN WITH INDICATION OF ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE E SHOCK. PRIOR TO THE TEAM PLACING THE RP FLEX THE PATIENT WAS KNOWN TO HAVE HAD CPR FOR A CARDIAC ARREST, AND WAS SUPPORTED BY INOTROPES, VASOPRESSORS, AND A VENT FOR RESPIRATORY NEEDS. THE UNDERLYING MEDICAL HISTORY WAS NOT SHARED. THE PUMP WAS SUPPORTING WHEN THE NURSING STAFF RELAYED THAT THE PATIENT HAD SUFFERED A STROKE IN THE OVERNIGHT HOURS ON DAY 1 OF THE SUPPORT. LATER THE TEAM CONFIRMED IT WAS A SMALL SUBDURAL HEMATOMA. THE PUMP SUPPORTED FOR 3 DAYS WHEN WEANED AND EXPLANTED. THE PATIENT DID SURVIVE THE STROKE. THE ANTICOAGULATION NECESSARY FOR THE PUMP PLACEMENT AND SUPPORT CAN CONTRIBUTE TO BLEEDING, WHETHER THE SYSTEMIC HEPARIN ANTICOAGULATION CONTRIBUTED TO THE SUBDURAL HEMATOMA WAS NOT SHARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79055 IMPELLA TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. - 1220648 2025503182 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1