BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24895120 · Received April 16, 2026

    Report

    Report Number
    1220648-2026-06863
    Event Type
    Injury
    Date Received
    April 16, 2026
    Date of Event
    April 10, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA. D4 SERIAL AND UDI NUMBERS UPDATED/CORRECTED. THE INVESTIGATION IS STILL ONGOING.

    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.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY TO SUPPORT THE 53 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 PUMP PLACEMENT THE PATIENT WAS SUPPORTED BY INOTROPES, VASOPRESSORS, AND A VENT FOR RESPIRATORY NEEDS. THE UNDERLYING MEDICAL HISTORY WAS NOT SHARED. ON THE DAY AFTER PUMP INSERTION THERE WAS AN ACCESS SITE BLEED OBSERVED BY THE MEDICAL STAFF. THIS HAD OCCURRED AFTER THE PATIENT WAS MOVED/ROLLED AND REPOSITIONED IN THE ICU BED. THE PATIENT WAS OBSERVED TO BE SUPRATHERAPEUTIC ON HEPARIN, SO THE TEAM HELD THE HEPARIN AND TREATED THE BLEED WITH A UNIT OF BLOOD. THE HEMOGLOBIN HAD DROPPED TO 7.4G/DL. ANTICOAGULATION NECESSARY FOR THE PUMP PLACEMENT AND SUPPORT CAN CONTRIBUTE TO ACCESS SITE BLEEDING. THE TEAM REDRESSED THE SITE, CHANGED THE SUTURE, APPLIED GENTLE PRESSURE, AND APPLIED SURGICELE AT THE GAUZE/DRESSING SITE. WITH DROPPING PLATELETS THE TEAM MADE DECISION TO DRAW THE LABS TO SEE IF THE PATIENT WAS SUFFERING FROM HITT THROMBOCYTOPENIA. AFTER ALL OF THESE MEASURES WERE TAKEN THE TEAM OBSERVED THE PUMP AND CABLE TO BE HANGING AND COVERED BY OTHER DEVICES/LINES, AND THIS WAS PUTTING TENSION ON THE ACCESS SITE. THEY ADJUSTED THE PUMP AND CABLE AND THE PUMP REMAINS ON WITH BLEED RESOLVING. THE PATIENT SUPPORT CONTINUES AND PATIENT HAS SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297695 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027861591 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1