BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 8496804 · Received April 9, 2019

    Report

    Report Number
    1220648-2019-00066
    Event Type
    Injury
    Date Received
    April 9, 2019
    Date of Event
    March 14, 2019
    Report Date
    March 14, 2019
    Manufacturer
    ABIOMED
    Product Code
    OZD
    UDI-DI
    813502011388
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MEDICAL FACILITY DID RETURN FOR ANALYSIS THE IMPELLA PUMP, BUT NOT THE ACCESS SITE INTRODUCER NOR THE CASE DATA LOGS. UPON INSPECTION OF THE PUMP THERE WAS AN OBSERVATION MADE OF A SLIGHT BEND AND BUCKLING OF THE PUMP'S REPOSISTIONING UNIT. THE CAUSE OF THE DEFECT WAS UNKNOWN. THE BUCKLING OF THE UNITE LIKELY CAUSED A LEAK PATH TO FORM FOR BLEEDING TO OCCUR AT THE ACCESS SITE. IT IS UNKNOWN WHAT CAUSED THE BUCKLING TO OCCUR. THE CAUSE OF THE ACCESS SITE BLEEDING AND HEMATOMA WAS MOST LIKELY THE BUCKLING. THE FAILURE MODE WILL BE MONITORED AND TRENDED.

    Description of Event or Problem · 1

    THE PATIENT WAS EXPERIENCING POST CARDIOTOMY CARDIOGENIC SHOCK AFTER HAVE CORONARY ARTERY BYPASS AND AORTIC AND MITRAL VALVE REPLACEMENTS. DUE TO THE SHOCK, THE TEAM CHOSE TO PLACE AN IMPELLA CP FOR SUPPORT. UPON TRANSFER FROM THE OPERATING ROOM TO THE ICU, THERE WAS A HEMATOMA THAT DEVELOPED AT THE IMPELLA ACCESS SITE. THE TEAM OBSERVED THE BLEEDING AT THE ACCESS SITE DURING THE FIRST 24 HOURS OF SUPPORT. ON THE SECOND DAY OF IMPELLA SUPPORT THE TEAM PLACED A FEMOSTOP AND INFUSED BLOOD PRODUCTS. AFTER 89 HOURS OF IMPELLA SUPPORT THE PATIENT CONDITION IMPROVED, THE PUMP WAS WEANED AND EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291282 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED IMPELLA CP 1397934 813502011388

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R