BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24576987 · Received March 12, 2026

    Report

    Report Number
    1220648-2026-05106
    Event Type
    Injury
    Date Received
    March 12, 2026
    Date of Event
    April 18, 2025
    Report Date
    May 8, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    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

    UPDATED INFORMATION: D4 UDI NUMBER UPDATED.

    Description of Event or Problem · 0

    A 78-YEAR-OLD MALE WAS ADMITTED FOR A NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION. THE PATIENT REQUIRED CORONARY ARTERY BYPASS GRAFTING (CABG) PLUS MITRAL VALVE REPLACEMENT (MVR) AND AN IMPELLA 5.5 WAS ELECTIVELY PLACED VIA DIRECT APPROACH FOR PREOPERATIVE HEMODYNAMIC STABILITY. THE PATIENT REQUIRED 1 UNIT OF BLOOD POST OPERATIVELY. THE PATIENT¿S CREATININE ELEVATED MOST LIKELY DUE TO HYPOVOLEMIA (CVP 4) SO THE PATIENT WAS GIVEN ALBUMIN. LABWORK SHOWED QUESTIONABLE HEMOLYSIS HOWEVER, THERE WERE NO CLINICAL SYMPTOMS NOTED AND THE LABWORK NORMALIZED AFTER VOLUME REPLACEMENT. THERE WERE NO ISSUES AND THE PATIENT WAS SUCCESSFULLY EXPLANTED ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628152 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026654085 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1