BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP

    MDR report key: 23163880 · Received September 28, 2025

    Report

    Report Number
    1220648-2025-46984
    Event Type
    Death
    Date Received
    September 28, 2025
    Date of Event
    August 29, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF THE REPORTED FAILURE MODE HAS BEEN COMPLETED. NO PRODUCT WAS RETURNED FOR INVESTIGATION. MAJOR BLEED: THE CAUSE OF THE BLEEDING IS DETERMINED TO BE USE ISSUE BECAUSE THE PEEL AWAY SHEATH WAS IN PLACE AGAINST BEST PRACTICE ADVICE OF THE PRIMARY ABIOMED SUPPORT ON-SITE AND OOZING OCCURRED AFTER TRANSFER TO ICU. DEVICE HISTORY REVIEW: THE DEVICE PASSED ALL THE POST STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION WAS UPDATED IN D7A (IS THIS A SINGLE-USE DEVICE?). ADDITIONAL INFORMATION WAS PROVIDED IN G4 (PMA/ 510(K)). 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

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

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT DURING SUPPORT ON IMPELLA 5.5 THE NURSE OBSERVED THAT THE PATIENT WAS EXPERIENCING ACCESS SITE BLEEDING AND REQUESTED ADVICE RELATED TO THE CARE THEREOF. THE PATIENT RECEIVED ONE UNIT OF BLOOD BUT WAS NOT STARTED ON SYSTEMIC ANTICOAGULATION. LABS WERE PENDING. THE NURSE WAS INFORMED THAT WE COULD NOT ADVISE ON THAT MATTER BEING THAT THE IMPLANTING PHYSICIAN CHOSE TO LEAVE THE PEEL-AWAY SHEATH IN PLACE AGAINST BEST PRACTICE ADVICE OF THE PRIMARY SUPPORT ON-SITE. THERE WAS SUPPORT OFFERED TO SUPPORT REMOVING THE SHEATH AND INSERTING THE REPOSITIONING SHEATH IF THE CARE TEAM CHOSE THAT IN THE PLAN OF CARE; HOWEVER, ADDITIONAL INFORMATION NOTED THAT THE PATIENT EXPIRED ON SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511935 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 IMPELLA CP 2026699595

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Required Intervention| D