BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_IMPELLA CP

    MDR report key: 24527537 · Received March 5, 2026

    Report

    Report Number
    1220648-2026-04589
    Event Type
    Injury
    Date Received
    March 5, 2026
    Date of Event
    December 19, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT-DEVICE INTERACTION PROBLEM / MAJOR BLEED: THE ROOT CAUSE OF THE ACCESS SITE ADVERSE EVENT WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Additional Manufacturer Narrative · 0

    B5 THE CLINICAL NARRATIVE WAS ADDED. D4 WAS REVISED. H6 MEDICAL DEVICE PROBLEM CODE WAS REVISED TO A01 AS A24 WAS ERRONEOUSLY REPORTED ON THE INITIAL.

    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: THIS REPORT DOCUMENTS A DISCUSSION REGARDING FUTURE PRODUCT DESIGN FEATURES AND A GENERAL ALLEGATION OF ACCESS SITE BLEEDING ASSOCIATED WITH CURRENT IMPELLA CP REPOSITIONING SHEATH SIZE MISMATCH. NO SPECIFIC PATIENT, PROCEDURE, OR DEVICE MALFUNCTION WAS IDENTIFIED, AND NO DEVICE WAS REMOVED DUE TO A FAILURE MODE. THE REPORTED CONCERN RELATES TO GENERAL ACCESS SITE ARTERIOTOMY BLEEDING RATHER THAN A CONFIRMED DEVICE FAILURE. 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

    DOCTOR POINTED OUT TO HIS CATHERIZATION LAB STAFF THAT THE NEW IMPELLA PRODUCT (CP10) SHOULD HOPEFULLY IMPROVE BLEEDING ISSUES EXPERIENCED WITH CRYOPRECIPITATES (CPS) FOR PATIENTS SENT TO THE INTENSIVE CARE UNIT (ICU) WITH THE REPOSITIONING SHEATH WHERE ARTERY DOES NOT RECOIL TO A SMALLER SIZE OF REPOSITIONING SHEATH. THIS COMPLAINT WILL BE CODED CONSERVATIVELY FOR BLEEDING ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582827 UNK_IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648

    Patients

    Seq Age Sex Outcome Treatment
    1