BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24899793 · Received April 16, 2026

    Report

    Report Number
    1220648-2026-06900
    Event Type
    Injury
    Date Received
    April 16, 2026
    Date of Event
    April 13, 2026
    Report Date
    April 16, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    04260113630280
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G1 (MANUFACTURER CONTACT FAX NUMBER) HAS BEEN ADDED AS THIS WAS OMITTED FROM THE INITIAL MW SUBMITTED. 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 CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED FOR D6 EXPLANT.

    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

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE IMPELLA DEVICE WAS EXPLANTED.

    Description of Event or Problem · 0

    AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY TO SUPPORT THE 66 YEAR OLD MALE PATIENT WHO HAD BEEN ADMITTED IN WITH INDICATION OF ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE E SHOCK. THIS CP REPLACED A PRIOR CP PUMP THAT HAD FAILED TO DELIVER. PRIOR TO THE CP INSERTION THE PATIENT WAS ON SUPPORT WITH VA-EXTRA CORPOREAL MEMBRANE OXYGENATION AND A VENT FOR RESPIRATORY NEEDS. THE MEDICAL TEAM IN THE EU DID NOT FURNISH ANY MEDICAL HISTORY FOR THIS PATIENT. ON DAY 4 OF THE SUPPORT THE PATIENT HAD DIALYSIS INITIATED FOR RENAL FAILURE. THE PUMP WAS NOT EXPLANTED FOR THE RENAL FAILURE AND SUPPORT CONTINUES TO DATE. RENAL FAILURE MAY BE INFLUENCED BY PATIENT-SPECIFIC FACTORS SUCH AS CRITICAL ILLNESS, UNDERLYING CARDIAC DYSFUNCTION, HEMODYNAMIC INSTABILITY, AND RENAL FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493330 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026706970 04260113630280

    Patients

    Seq Age Sex Outcome Treatment
    1