BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24899962 · Received April 16, 2026

    Report

    Report Number
    1220648-2026-06903
    Event Type
    Injury
    Date Received
    April 16, 2026
    Date of Event
    April 10, 2026
    Report Date
    April 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
    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.

    Description of Event or Problem · 0

    AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY TO SUPPORT THE 72 YEAR OLD FEMALE WHO HAD BEEN ADMITTED IN WITH KNOWN CORONARY ARTERY DISEASE AND PLAN FOR A PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PCI). AT THE TIME OF PUMP INSERTION THE PATIENT WAS IN SCAI STAGE C SHOCK. PRIOR TO THE PUMP PLACEMENT THE PATIENT WAS ON OXYGEN FOR RESPIRATORY NEEDS, BUT OTHER UNDERLYING HISTORY WAS NOT KNOWN. THE PUMP SUPPORTED FOR THE PCI AND WAS EXPLANTED AFTER 25 HOURS. POST EXPLANT THE TEAM USED PERCLOSE TO ACHIEVE HEMOSTASIS AT THE GROIN ACCESS SITE. THE SITE WAS STILL OOZING, WHICH PROMPTED THE ICU TEAM TO APPLY MANUAL PRESSURE AND A FEMSTOP WAS PLACED. THE PULSES BECAME LOST AND THE TEAM HAD VASCULAR SURGERY TEAM INTERVENE, AS THEY PERFORMED THROMBECTOMY AND A FASCIOTOMY. THE PATIENT SURVIVED THE HARM. ISCHEMIA MAY BE INFLUENCED BY PATIENT-SPECIFIC FACTORS SUCH AS SEVERE PERIPHERAL VASCULAR DISEASE, UNDERLYING CRITICAL ILLNESS, HEMODYNAMIC INSTABILITY, AND VASCULAR ACCESS CHARACTERISTICS. THE OOZE OBSERVED FROM AN ACCESS SITE BLEED CAN BE CONTRIBUTED TO BY THE ANTICOAGULATION NECESSARY FOR THE PUMP PLACEMENT AND SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247711 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027860690 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1