BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 20540479 · Received October 26, 2024

    Report

    Report Number
    1220648-2024-21219
    Event Type
    Injury
    Date Received
    October 26, 2024
    Date of Event
    March 24, 2023
    Report Date
    March 7, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS. AS NOTED IN THE IMPELLA IFU: IMPELLA CP WITH SMART ASSIST SYSTEM ¿PHYSICIANS SHOULD EXERCISE SPECIAL CARE WHEN INSERTING THE IMPELLA CATHETER IN PATIENTS WITH KNOWN OR SUSPECTED UNREPAIRED ABDOMINAL AORTIC ANEURYSM OR SIGNIFICANT DESCENDING THORACIC AORTIC ANEURYSM OR DISSECTION OF THE ASCENDING, TRANSVERSE, OR DESCENDING AORTA.¿ CAUTION: ¿PHYSICIANS SHOULD EXERCISE SPECIAL CARE WHEN INSERTING THE IMPELLA CATHETER DURING ACTIVE CARDIOPULMONARY RESUSCITATION (CPR). IN ADDITION, ACTIVE CPR MANEUVERS MAY CHANGE THE POSITION OF THE IMPELLA DEVICE, INTRODUCING THE RISK OF CARDIAC OR VASCULAR INJURY (INCLUDING VENTRICULAR PERFORATION). CHECK THAT THE PUMP IS POSITIONED CORRECTLY AFTER CPR WITH CHEST X-RAY GUIDANCE.¿

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE REPORTED PUMP STOP AND VASCULAR DAMAGE ISSUE HAS BEEN COMPLETED. THE IMPELLA DEVICE WAS RECEIVED FROM THE CUSTOMER AND AN INVESTIGATION REGARDING THE RETURNED DEVICE HAS BEEN COMPLETED. THE EVALUATION OF THE DEVICE NOTED THAT THE RETURNED PUMP WAS VISUALLY INSPECTED AND HORIZONTAL CREASE WAS OBSERVED ON THE CANNULA. UNDER BORESCOPE INSPECTION, A TANGLED FRACTURED RED LUMEN WAS OBSERVED IN THE CANNULA NEAR THE CANNULA CREASE. THE DEVICE PASSED ALL POST-STERILE INSPECTION CHECKS. THE CAUSE OF THE ISSUE WAS A RED LUMEN REMOVAL ISSUE. A CREASE IN THE CANNULA WAS OBSERVED THAT LIKELY CONTRIBUTED TO THE RED LUMEN FRACTURE. THE ROOT CAUSE OF THE VASCULAR DAMAGE COULD NOT BE DETERMINED AS INSUFFICIENT CLINICAL DETAILS WERE PROVIDED. THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THAT THERE WAS AN IMMEDIATE PUMP STOP. EVENTUALLY PUMP BECAME ¿FUNCTIONAL¿ BUT NOT WITH HIGH RELIABILITY. THE PUMP WAS EXPLANTED AND REPLACED. DURING THE EXPLANT THERE WAS VASCULAR DAMAGE DISCOVERED AT LEFT FEMORAL ARTERY (LFA) CLOSURE SITE. TEN UNITS OF PACKED RED BLOOD CELLS (PRBC ) WERE GIVEN. ADDITIONAL INFORMATION WAS PROVIDED THAT NOTED THE PATIENT EXPIRED. MEDICAL SAFETY REVIEW OF THE EVENT NOTED USE OF THE DEVICE CANNOT CONCLUSIVELY BE ASSOCIATED WITH THE OUTCOME (PATIENT'S DEMISE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1680160 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. PUMP 371 14F LT CMR SET 2023277660 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention