BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CPSA C9+ SET, OUS

    MDR report key: 24542064 · Received March 8, 2026

    Report

    Report Number
    1220648-2026-04689
    Event Type
    Death
    Date Received
    March 8, 2026
    Date of Event
    February 26, 2026
    Report Date
    March 8, 2026
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. CORRECTED INFORMATION WAS PROVIDED IN D4. UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY OMITTED FROM THE INITIAL REPORT.

    Additional Manufacturer Narrative · 0

    ADDED: D3, E4. CORRECTED: D4 (SERIAL). HEMATOMA/MAJOR BLEED/ASAE: THE CAUSE OF THE ACCESS SITE ADVERSE EVENT WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE HAS NOT BEEN RECEIVED FROM THE CUSTOMER. THEREFORE, INVESTIGATION OF THE DEVICE IS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 0

    AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY TO SUPPORT THE 75-YEAR-OLD MALE PATIENT WHO HAD BEEN ADMITTED IN WITH INDICATION OF ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE B SHOCK. THE PATIENT WAS ON A BILEVEL POSITIVE AIRWAY PRESSURE (BIPAP) FOR RESPIRATORY NEEDS PRIOR TO THE PUMP PLACEMENT, BUT OTHER MEDICAL HISTORY AND COMORBIDITIES WERE NOT SHARED. AFTER TRANSFER FROM THE CATHETERIZATION LAB TO THE ICU THE TEAM OBSERVED A HEMATOMA AT THE ACCESS SITE. THE TEAM ATTEMPTED TO REMEDY THE ISSUE WITH Z-SUTURES TWICE. NO BLOOD PRODUCTS WERE GIVEN BUT AFTER HOURS OF SUPPORT THE PATIENT HAD CARE WITHDRAWN AND THE PATIENT EXPIRED. ANTICOAGULATION NECESSARY FOR THE PUMP PLACEMENT AND SUPPORT CAN CONTRIBUTE TO ACCESS SITE BLEEDING. THE DEATH IS CONSERVATIVELY BEING REPORTED ALTHOUGH AN UNLIKELY CONTRIBUTING FACTOR TO THE DEATH, AND MORE LIKELY THE PATIENT'S PRESENTING NATIVE CRITICAL CONDITION AS PRESENTED IN SCAI STAGE B.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197173 IMPELLA CPSA C9+ SET, OUS TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMPP OZD ABIOMED, INC. 2027830367

    Patients

    Seq Age Sex Outcome Treatment
    1