BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24758103 · Received April 1, 2026

    Report

    Report Number
    1220648-2026-06266
    Event Type
    Injury
    Date Received
    April 1, 2026
    Date of Event
    March 25, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D9: UPDATED DEVICES RETURN INFORMATION.

    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 (B)(6) YEAR OLD MALE PATIENT WHO HAD BEEN ADMITTED IN WITH INDICATION OF ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK WITH PRESENTATION IN SCAI STAGE C SHOCK. NO MEDICAL HISTORY WAS SHARED. ON THE DAY OF INSERTION, THE PUMP WAS SUPPORTING WHEN THERE WAS AN OBSERVATION MADE OF SUCTION THAT WAS REMEDIED BY THE REDUCTION IN PUMP P LEVELS. AS THE SUPPORT CONTINUED THERE WAS A BLEED AT THE ACCESS SITE AND CONCERNS OF GASTROINTESTINAL BLEED AS THE STOOL WAS BLOODY. THE TEAM GAVE UNITS OF BLOOD AND STOPPED THE HEPARIN. AFTER 4 DAYS THE PUMP WAS WEANED AND EXPLANTED. PATIENT SURVIVED. ANTICOAGULATION NECESSARY FOR THE PUMP PLACEMENT AND SUPPORT CAN CONTRIBUTE TO ACCESS SITE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470049 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027817364 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1