BEUDAMED
    FDA Adverse Event Death Summary report: N

    TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

    MDR report key: 24883476 · Received April 15, 2026

    Report

    Report Number
    1220648-2026-06791
    Event Type
    Death
    Date Received
    April 15, 2026
    Date of Event
    April 10, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012200
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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. CORRECTED INFORMATION HAS BEEN PROVIDED IN D4 (SERIAL); D10 (CONCOMITANT MED PRODUCTS); E1; E3. THE CAUSE OF THE POSITIONING ISSUE WAS LIKELY USE RELATED AS EVIDENCED BY CLINICAL INFORMATION MENTIONING PATIENT PULLED ON THE DEVICE CAUSING IMPROPER POSITIONING.

    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

    ADDITIONAL INFORMATION WAS RECEIVED: THE DEVICE WAS DISCARDED.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY TO SUPPORT THE 67 YEAR OLD MALE PATIENT WHO HAD BEEN ADMITTED IN WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE D AT THE TIME OF CP PUMP PLACEMENT. THE CP WAS INSERTED AS CARE ESCALATION FROM AN INTRAAORTIC BALLOON PUMP. THE UNDERLYING MEDICAL HISTORY WAS NOT SHARED. WHILE ON PUMP SUPPORT THE CONSOLE ALARMED FOR THE PUMP BEING OUT OF POSITION. THE PATIENT HAD PULLED ON THE PUMP. THE PHYSICIAN REPOSITIONED THE PUMP WITH IMAGING. THE PATIENT DID EXPIRE AFTER THE ONE DAY OF SUPPORT WHEN THE CARE WAS WITHDRAWN. THE DEATH IS CONSERVATIVELY BEING REPORTED ALTHOUGH AN UNLIKELY CONTRIBUTING FACTOR TO THE DEATH, AND MORE LIKELY THE PATIENT'S PRESENTING NATIVE CRITICAL CONDITION AS PRESENTED IN SCAI STAGE D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389527 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027819120 00813502012200

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Death| R INTRAAORTIC BALLOON PUMP