BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25082119 · Received May 5, 2026

    Report

    Report Number
    1220648-2026-07492
    Event Type
    Injury
    Date Received
    May 5, 2026
    Date of Event
    April 26, 2026
    Report Date
    May 5, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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

    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 E4 UPON REVIEW, IT WAS IDENTIFIED THAT THE INFORMATION WAS INADVERTENTLY NOT SUBMITTED IN THE INITIAL REPORT. THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY TO SUPPORT THE 63 YEAR OLD MALE PATIENT WHO HAD BEEN ADMITTED IN WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE C SHOCK AT PUMP INSERTION. UNDERLYING MEDICAL HISTORY WAS NOT SHARED. THE CP WAS SUPPORTING WHEN ON THE DAY AFTER IMPLANT THE TEAM OBSERVED THE PATIENT COULD NO LONGER MOVE THE RIGHT SIDE OF HIS BODY. CT IMAGING CONFIRMED A STROKE OF EMBOLIC NATURE. TREATMENT OF THE STROKE, IF ANY, WAS NOT SHARED. ON THE 3RD DAY OF SUPPORT THE PUMP WAS WEANED AND EXPLANTED. THE PATIENT DID SURVIVE THE STROKE. THE STROKE IS BEING REPORTED ON THE PRODUCT DUE TO THE INABILITY TO CONCLUSIVELY DISSOCIATE THE PRODUCT FROM THE PATIENT HARM AS NOT ALL CLINICAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203088 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027867965 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1