BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 20753988 · Received November 21, 2024

    Report

    Report Number
    1220648-2024-23861
    Event Type
    Injury
    Date Received
    November 21, 2024
    Date of Event
    October 30, 2024
    Report Date
    December 30, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE VASCULAR DAMAGE HAS BEEN COMPLETED. NO PRODUCT WAS RETURNED FOR EVALUATION. CLINICAL DETAILS NOTED THAT PATIENT HAD HEREDITARY HEMORRHAGIC TELANGIECTASIA (HHT) THAT CAUSED ABNORMALLY FORMED BLOOD VESSELS. UPON INSERTION OF INTRODUCER, THE PHYSICIAN NOTED DIFFICULTY WHEN ADVANCING THE SHEATH BUT WAS ABLE TO EVENTUALLY PLACE SHEATH. AFTER PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, AN ANGIOGRAM SHOWED DISSECTION IN THE RIGHT FEMORAL ARTERY, BUT NO VASCULAR REPAIR WAS NEEDED. AS THE CUSTOMER REPORTED, THE VASCULAR DAMAGE AGAINST THE 14 FRENCH INTRODUCER, THE PRODUCT INVESTIGATED WAS CHANGED TO THE 14 FRENCH INTRODUCER. THE ROOT CAUSE OF THE VASCULAR DAMAGE - PERIPHERAL VESSEL WAS MOST LIKELY PATIENT CONDITION RELATED AS THE PATIENT HAD HHT. B.7 INFORMATION WAS INADVERTENTLY OMITTED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-23861 AND WAS ADDED. H.5 REVISED AS IT SHOULD HAVE BEEN YES ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-23861.

    Description of Event or Problem · 0

    THE US COMPLAINANT HAD A CP PUMP PLACED FOR A PATIENT WITH MULTIPLE CARDIAC AND SYSTEMIC COMORBIDITIES. THE PATIENT WAS IN NEED OF A HIGH-RISK PERCUTANEOUS CARDIAC INSERTION (HRPCI) WITH IMPELLA SUPPORT. THE TEAM HAD DIFFICULTY WITH DELIVERING BUT, THE SHEATH AND PUMP WERE PLACED. UPON EXPLANT A VASCULAR DISSECTION WAS OBSERVED IN THE RIGHT FEMORAL ARTERY (RFA). TEAM PERFORMED BALLOON TAMPONADE AND PLACED COVERED STENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2600798 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2025526906 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention