BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 24745990 · Received March 31, 2026

    Report

    Report Number
    1220648-2026-06192
    Event Type
    Injury
    Date Received
    March 31, 2026
    Date of Event
    March 24, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D6B: ADDED EXPLANT DATE.

    Additional Manufacturer Narrative · 0

    D4: CORRECTED THE SERIAL NUMBER. D6B: ADDED EXPLANT DATE. H6: ADDED A140505 AND A141204.

    Additional Manufacturer Narrative · 0

    D6B: UPDATED THE EXPLANT DATE. 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

    B1: ADDED PRODUCT PROBLEM. B5: UPDATED CLINICAL REVIEW. H6: ADDED CODES A140505 AND A141204.

    Description of Event or Problem · 0

    AN IMPELLA CP WAS INSERTED VIA LEFT FEMORAL ARTERY IN A 73 YEAR OLD MALE FOR ACUTE MYOCARDIAL INFARCTION WITH CARDIOGENIC SHOCK. THE PATIENT'S COMORBIDITIES WERE UNKNOWN. THE PATIENT'S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS SCAI STAGE D. ON DAY 6 OF SUPPORT, WHILE IN THE INTENSIVE CARE UNIT, BLEEDING WAS REPORTED AT THE ACCESS SITE. SYSTEMIC HEPARIN WAS TURNED OFF, MULTIPLE DRESSING CHANGES COMPLETED, AND ANGLE MATCHING DISCUSSED. NO ADDITIONAL DETAILS WERE PROVIDED. THE PATIENT CONTINUED ON SUPPORT AT THE TIME OF REPORTING. BLEEDING IS CONSISTENT WITH ACCESS SITE COMPLICATIONS AS A RESULT OF LARGE BORE FEMORAL PROCEDURES AND THE ANTICOAGULATION AND PURGE REQUIREMENTS ASSOCIATED WITH IMPELLA SUPPORT. IT IS UNKNOWN WHETHER RECOMMENDED BEST PRACTICES FOR ACCESS MANAGEMENT WERE FOLLOWED TO MITIGATE THE RISK OF BLEEDING.

    Description of Event or Problem · 0

    AN IMPELLA CP DEVICE WAS INSERTED VIA THE LEFT FEMORAL ARTERY IN A 73-YEAR-OLD MALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK. THE PATIENT¿S COMORBIDITIES WERE UNKNOWN. THE PATIENT¿S CLINICAL CONDITION PRIOR TO INITIATION OF SUPPORT WAS CONSISTENT WITH SCAI SHOCK STAGE D. ON DAY 6 OF IMPELLA SUPPORT, WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT, BLEEDING WAS NOTED AT THE FEMORAL ACCESS SITE. SYSTEMIC HEPARIN WAS DISCONTINUED, MULTIPLE DRESSING CHANGES WERE PERFORMED, AND ACCESS-SITE ANGLE MATCHING WAS DISCUSSED. NO ADDITIONAL PROCEDURAL DETAILS WERE PROVIDED. THE PATIENT REMAINED ON IMPELLA SUPPORT AT THE TIME. SUBSEQUENTLY, THE REGISTERED NURSE CONTACTED THE TEAM REGARDING A SUDDEN PUMP STOP. THERE WERE NO PRECEDING ALARMS AND NO REPORTED PATIENT MOVEMENT AT THE TIME OF THE EVENT. THE PUMP WAS SUCCESSFULLY RESTARTED WITH GRADUAL RAMP-UP TO PERFORMANCE LEVEL P-6. SATURATED FLOW READINGS WERE NOTED WHILE THE NURSE REPORTED THE VALUES. THE LOCAL CARE TEAM PLANNED TO EVALUATE THE NEED FOR IMPELLA EXCHANGE; HOWEVER, THE PATIENT REMAINED HEMODYNAMICALLY STABLE, AND SUPPORT CONTINUED FOLLOWING PUMP RESTART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269106 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027838840 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1