BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA RP

    MDR report key: 20221143 · Received September 15, 2024

    Report

    Report Number
    1220648-2024-17936
    Event Type
    Injury
    Date Received
    September 15, 2024
    Date of Event
    March 2, 2022
    Report Date
    September 15, 2024
    Manufacturer
    ABIOMED. INC.
    Product Code
    PXY
    UDI-DI
    00813502011029
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. INSTRUCTIONS FOR USE FOR THE RELATED EVENT ARE AS FOLLOWS: IMPELLA RP WITH SMART ASSIST SYSTEM WITH AUTOMATED IMPELLA CONTROLLER SECTION: WARNINGS AND CAUTIONS ¿MAKE SURE THERE IS NO BLEEDING AT THE TRANSITION FROM THE REPOSITIONING SHEATH TO THE INTERNAL JUGULAR VEIN. CLOSE AND DRESS THE WOUND ¿BE SURE THAT THE STOPCOCK ON THE REPOSITIONING SHEATH IS ALWAYS KEPT IN THE CLOSED POSITION. SIGNIFICANT BLEED BACK CAN RESULT IF THE STOPCOCK IS OPEN.¿ ¿MAKE SURE THERE IS NO BLEEDING AT THE TRANSITION FROM THE REPOSITIONING SHEATH TO THE FEMORAL VEIN. CLOSE AND DRESS THE WOUND.¿ THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A PATIENT WITH POST CARDIOTOMY CARDIOGENIC SHOCK / LOW CARDIAC OUTPUT SYNDROME WAS IMPLANTED WITH AN IMPELLA RP FOR MECHANICAL CIRCULATORY SUPPORT. DURING SUPPORT, THE PATIENT EXPERIENCED SIGNIFICANT BLEEDING AFTER THE PEEL-AWAY SHEATH WAS REMOVED AND REPOSITIONING SHEATH WAS ADVANCED FORWARD. THE PHYSICIAN HELD PRESSURE AND PLACED A TIGHT MATTRESS SUTURE AROUND DEVICE. IT WAS REPORTED THAT THE BLEEDING WAS ABLE TO BE CONTROLLED AFTER INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1130370 IMPELLA RP TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PXY ABIOMED. INC. IMPELLA RP 2022039123 00813502011029

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention