BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP 371 14F LT CMR SET

    MDR report key: 24158153 · Received January 22, 2026

    Report

    Report Number
    1220648-2026-01345
    Event Type
    Injury
    Date Received
    January 22, 2026
    Date of Event
    January 16, 2026
    Report Date
    January 22, 2026
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E4 WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: MAJOR BLEED/ACCESS SITE ADVERSE EVENT: THE CAUSE OF THE ACCESS SITE ADVERSE EVENT WAS USER RELATED DUE TO FAILURE OF PERCLOSE. DEVICE HISTORY LOT: DEVICE LOT: 1924856. DEVICE HISTORY BATCH: SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW: THE PUMP SN (B)(6) PASSED ALL THE POST STERILE INSPECTION CHECKS.

    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 DEVICE WAS INSERTED VIA THE LEFT FEMORAL ARTERY IN AN 87-YEAR-OLD MALE PATIENT TO PROVIDE HEMODYNAMIC SUPPORT DURING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). FOLLOWING REMOVAL OF THE IMPELLA CP, TWO PERCLOSE CLOSURE ATTEMPTS WERE UNSUCCESSFUL. ONGOING BLEEDING FROM THE FEMORAL ACCESS SITE REQUIRED PROLONGED MANUAL PRESSURE. LABORATORY EVALUATION DEMONSTRATED A TWO-POINT DROP IN HEMOGLOBIN, AND THE PATIENT RECEIVED TWO UNITS OF RED BLOOD CELLS. HEMOSTASIS WAS ULTIMATELY ACHIEVED WITH MANUAL PRESSURE. THE IMPELLA CP WILL BE CODED FOR MAJOR BLEED, BLOOD TRANSFUSION, AND SURGICAL INTERVENTION. THE ACCESS SITE BLEED IS LISTED AS A POTENTIAL ADVERSE EVENT AND IS CONSISTENT WITH KNOWN DEVICE-RELATED AND PATIENT-RELATED FACTORS DOCUMENTED IN THE INSTRUCTIONS FOR USE (IFU), INCLUDING ANTICOAGULATION AND PURGE REQUIREMENTS ASSOCIATED WITH IMPELLA SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219175 PUMP 371 14F LT CMR SET TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. PUMP 371 14F LT CMR SET 2026670067 813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Male Required Intervention