BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA CP

    MDR report key: 22970779 · Received September 4, 2025

    Report

    Report Number
    1220648-2025-46149
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    August 5, 2025
    Report Date
    September 4, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY- THE IMPELLA CP PUMP WAS NOT RETURNED. DATA LOGS ARE NOT APPLICABLE FOR REPORTED FAILURES. DELIVERY ISSUES(UNABLE TO DELIVER OR ADVANCE): AS PER CLINICAL, IT WAS REPORTED THE PUMP DID NOT CROSS ILIAC ARTERY DUE TO CALCIFIED VESSELS AT FEMORAL. THE CAUSE OF DELIVERY ISSUES WAS PATIENT RELATED SINCE PUMP WAS UNABLE TO PASS VASCULATURE DUE TO CALCIFIED VESSEL. PRODUCT DAMAGE(CATHETER KINK): AS PER CLINICAL, IT WAS REPORTED THE THERE WAS CATHETER KINK DAMAGED DUE TO RESISTANCE AT FEMORAL ARTERY. PATIENT HAD CALCIFIED VESSEL CONDITION. THE CAUSE OF PRODUCT DAMAGE(CATHETER KINK) WAS DUE TO PATIENT CONDITION RELATED. DEVICE HISTORY LOT- DEVICE LOT: 1931536. DEVICE HISTORY BATCH- SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW- THE PUMP SN (B)(6) PASSED ALL THE INCOMING POST STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    PATIENT-SPECIFIC INFORMATION SECTION A5: ETHNICITY AND A6: RACE ARE UNKNOWN. DEVICE STATUS: THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER; THEREFORE, AN EVALUATION/ANALYSIS 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 THE INSERTION OF THE INITIAL IMPELLA CP DEVICE TO A PATIENT UNDERGOING A HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION WAS UNSUCCESSFUL AS IT WAS UNABLE TO CROSS THE ILIAC ARTERY DUE TO CALCIUM AND THE USE OF A SHORT SHEATH (13CM). THE PHYSICIAN MADE THE DECISION TO SHOCKWAVE THE COMMON FEMORAL AND ILLIAC ARTERIES AND UTILIZE A 25CM PEEL-AWAY SHEATH. HOWEVER, UPON VISUAL INSPECTION OF THE PUMP DAMAGE WAS OBSERVED. A NEW IMPELLA CP DEVICE WAS DECIDED, WHICH WAS SUCCESSFULLY IMPLANTED, AND THE PERCUTANEOUS CORONARY INTERVENTION WAS COMPLETED WITHOUT ANY ISSUES. THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2095704 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026723019 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female