BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24686600 · Received March 25, 2026

    Report

    Report Number
    1220648-2026-05904
    Event Type
    Injury
    Date Received
    March 25, 2026
    Date of Event
    March 16, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    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. THE CAUSE OF THE ACCESS SITE ADVERSE EVENT WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Additional Manufacturer Narrative · 0

    A6 IS UNKNOWN. 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

    D3 (MANUFACTURER FAX) 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.

    Description of Event or Problem · 0

    AN IMPELLA CP DEVICE WAS INSERTED INTO THE RIGHT FEMORAL ARTERY IN A 57-YEAR-OLD MALE PATIENT WITH A PAST MEDICAL HISTORY OF CORONARY ARTERY DISEASE (CAD), PRESENTING IN SCAI STAGE A SHOCK, PRIOR TO INITIATION OF SUPPORT. THE IMPELLA WAS INSERTED FOR VENTRICULAR SUPPORT FOR A BAILOUT OF A PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING THE PROCEDURE, THERE WAS A HEMATOMA AT THE ACCESS SITE. MANUAL PRESSURE WAS APPLIED TO REDUCE THE SIZE AND OBTAIN HEMOSTASIS. THE ACTIVATED CLOTTING TIME (ACT) WAS 324. THE PATIENT WAS ON HEPARIN DURING THE PROCEDURE. THE FOLLOWING DAY, THE IMPELLA WAS SUCCESSFULLY WEANED. THE POST-PROCEDURE OUTCOME IS SURVIVED AT EXPLANT. THE IMPELLA FUNCTIONED AT P-4 AT 2.6L/MIN AS INTENDED. BLEEDING (HEMATOMA) IS A KNOWN RISK DUE TO THE IMPELLA'S ANTICOAGULATION AND PURGE REQUIREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403926 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026810455 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1