BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24817902 · Received April 8, 2026

    Report

    Report Number
    1220648-2026-06522
    Event Type
    Injury
    Date Received
    April 8, 2026
    Date of Event
    March 31, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 INVESTIGATION: TYPE, FINDINGS, AND CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    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

    CLINICAL NARRATIVE: AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY TO SUPPORT THE 59-YEAR-OLD MALE PATIENT WITH KNOWN CORONARY ARTERY DISEASE AND PLAN FOR PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PCI). THE PATIENT'S UNDERLYING MEDICAL HISTORY WAS NOT SHARED. THE PUMP WAS PLACED FOR THE PCI HOWEVER, THERE WAS SUCTION AND SO THE TEAM DROPPED THE P LEVELS, AND THIS RESOLVED. THE PATIENT DEVELOPED A FEVER AND PULSES WERE LOST TO THE LEFT LEG. THE PATIENT HAD ELEVATED LABS AND WAS SUPRATHERAPEUTIC ON NO ANTICOAGULATION. THE PATIENT'S URINE COLOR CHANGED AND THE HEMATURIA PROMPTED THE TEAM TO ASSESS THE PUMP WITH ECHO IMAGING BUT, THE PLACEMENT WAS APPROPRIATE. AFTER JUST OVER 1 DAY OF SUPPORT THE TEAM WEANED AND EXPLANTED THE PUMP. THE PATIENT SURVIVED THE PCI AND PUMP EXPLANT. ISCHEMIA MAY BE INFLUENCED BY PATIENT-SPECIFIC FACTORS SUCH AS SEVERE PERIPHERAL VASCULAR DISEASE, UNDERLYING CRITICAL ILLNESS, HEMODYNAMIC INSTABILITY, AND VASCULAR ACCESS CHARACTERISTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493077 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027855344 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1