BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24466139 · Received February 27, 2026

    Report

    Report Number
    1220648-2026-04181
    Event Type
    Injury
    Date Received
    February 27, 2026
    Date of Event
    November 2, 2025
    Report Date
    May 4, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 SERIAL NUMBER UPDATED.

    Additional Manufacturer Narrative · 0

    D4: CORRECTED THE SERIAL NUMBER AND UDI.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION WAS PROVIDED IN D1 (BRAND NAME). H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    A (B)(6) MALE PRESENTED WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (SCAI STAGE D). THE PATIENT WAS EVALUATED FOR SURGICAL REVASCULARIZATION AND THE DEVICE WAS IMPLANTED AS A BRIDGE TO CORONARY ARTERY BYPASS GRAFTING (CABG).THE DEVICE WAS SUCCESSFULLY IMPLANTED WITHOUT REPORTED PROCEDURAL COMPLICATIONS. NO ADDITIONAL DETAILED CLINICAL COURSE OR HOSPITAL DOCUMENTATION WAS PROVIDED TO THE MANUFACTURER. DURING FOLLOW-UP COMMUNICATION WITH THE TREATING TEAM, IT WAS MENTIONED THAT THE PATIENT EXPERIENCED A STROKE DURING THE HOSPITALIZATION. THE TEAM ALSO REPORTED THAT THE PATIENT WAS SUCCESSFULLY WEANED FROM THE DEVICE ON DAY 8 POST-IMPLANT.NO FURTHER INFORMATION REGARDING DIAGNOSTICS, TREATMENTS, PATIENT CONDITION AFTER WEANING, OR ULTIMATE CLINICAL OUTCOME WAS MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571423 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026745774 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1