BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA RP

    MDR report key: 6125639 · Received November 23, 2016

    Report

    Report Number
    1220648-2016-00032
    Event Type
    Death
    Date Received
    November 23, 2016
    Date of Event
    September 6, 2016
    Report Date
    September 6, 2016
    Manufacturer
    ABIOMED EUROPE, GMBH (GERMANY)
    Product Code
    OJE
    UDI-DI
    00813502010022
    PMA / PMN Number
    H140001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEFINITIVE ROOT CAUSE OF THE IMPELLA RP PUMP STOP WAS INGESTION OF BIOMATERIAL. THE INGESTED BIOMATERIAL WRAPPED AROUND THE IMPELLER. THE DATA LOG INVESTIGATION AND PRODUCT TESTING FOUND THAT SPIKES IN MOTOR CURRENT AND HIGH PURGE PRESSURE WERE EVIDENT. THE PRODUCT WAS RUN IN THE LAB AND NO PUMP STOPS OCCURRED. THIS COULD HAVE BEEN DUE TO DIFFERENT CONDITIONS THAN FOUND IN THE PROCEDURE. THE BIOMATERIAL WAS MOST LIKELY INTERFERING WITH THE PURGE FLOW, CREATING THE BEHAVIOR/ALARMS SEEN IN THE CASE, AND THE EVENTUAL PUMPS STOPS. THE TEAM DID NOT MAKE THE CHOICE TO REPLACE THE PUMP AFTER EXPERIENCING THE PUMP STOPS AND RESTARTING THE PUMP. THE PATIENT EXPIRED WHILE THE VA-ECMO WAS BEING SETUP FOR SUPPORT. WITHIN THE IFU THERE ARE INSTRUCTIONS ON WHAT TO DO UPON A PUMP STOP ALARM. THEY ARE: REPLACE WHITE CONNECTOR CABLE. SWITCH TO BACKUP CONTROLLER. REPLACE IMPELLA CATHETER. THE INGESTED BIOMATERIAL COULD HAVE BEEN DUE TO THE PATIENT'S UNDERLYING CONDITION OF A PFO AND THE BLOOD SHUNTING. THE PFO AND THE ASSOCIATED SHUNTING COULD HAVE CONTRIBUTED TO CLOT FORMATION, BUT THIS IS UNKNOWN. NO CORRECTIVE ACTION IS RECOMMENDED AS THE FAILURE IS DUE TO PATIENT CONDITION. FAILURES OF THIS TYPE WILL CONTINUE TO BE MONITORED AND TRACKED. (B)(4). THIS MDR WAS ONE OF THE 13 AND WAS ORIGINALLY SUBMITTED IN THE TEST ENVIRONMENT ON 10/03/2016 AND THE REASONS STATED ABOVE ARE THE REASONS IT IS BEING SUBMITTED BEYOND THE 30 DAY WINDOW. (B)(4).

    Description of Event or Problem · 1

    A (B)(6) MALE WAS ADMITTED TO FACILITY IN (B)(6) WITH A ST ELEVATION MYOCARDIAL INFARCTION. THE RIGHT CORONARY ARTERY WAS OCCLUDED. REVASCULARIZATION WAS ATTEMPTED, HOWEVER, THIS ATTEMPT WAS NOT SUCCESSFUL. THE PATIENT WAS MONITORED FOR TWO DAYS. THE PATIENT CONTINUED TO DETERIORATE AND BECAME HEMODYNAMICALLY UNSTABLE, WITH A LOW BLOOD PRESSURE, INCREASING LACTATE LEVELS, AND AN ECHO SHOWING RIGHT VENTRICULAR FAILURE. THE DECISION WAS MADE TO PLACE AN IMPELLA RP. THE PLACEMENT OF THE RP WAS DIFFICULT, HOWEVER SUCCESSFUL, AND SUPPORT WAS INITIATED. WITHIN 30 MINUTES OF SUPPORT, THE IMPELLA CONSOLE DID ALARM FOR LOW PURGE FLOW AND INCREASED PURGE PRESSURE. TROUBLESHOOTING DID NOT REVEAL ANY KINK IN THE PUMP. THE TEAM FURTHER TROUBLESHOT BY EXCHANGING THE PURGE CASSETTE. THE ALARM DID NOT RESOLVE, BUT SUPPORT REMAINED ON AND OVER THE FOLLOWING HOURS THE FLOW ISSUE DID RESOLVE. APPROXIMATELY SIX HOURS LATER, THE RP STOPPED RUNNING DUE TO HIGH MOTOR CURRENT. ONCE THE RP STOPPED, THE PATIENT DID EXPERIENCE SEVERE SHOCK WITH REDUCED OXYGENATION AND LOW BLOOD PRESSURE. THE RP WAS RESTARTED AND AN ECHO WAS PERFORMED TO OBSERVE THE PATIENT AND PUMP FUNCTION. THE ECHO DID SHOW SOME MOVEMENT OF THE RP, THOUGH THE POSITION WAS STILL ACROSS THE PULMONIC VALVE. THERE WAS EVIDENCE OF MASSIVE RIGHT TO LEFT SHUNTING (AT THE KNOWN PFO), POOR ARTERIAL OXYGENATION, AND RISING LACTIC ACIDOSIS. DURING THIS TIME, THE RP PUMP WAS FLOWING AT 3-3.5L/MINUTE WITH ALMOST ABSENT PULSATILITY. THE TEAM CHOSE AT THIS TIME TO CHANGE THE THERAPY/SUPPORT TO VENO-ARTERIAL (VA) ECMO. UNFORTUNATELY, THE PATIENT DID EXPIRE PRIOR TO THE VA ECMO LOOP BEING PLACED FOR SUPPORT. ACCORDING THE PHYSICIAN THE PATIENT EXPIRED AFTER THE SUBSEQUENT FAILURE TO RESTORE PULMONARY FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775125 IMPELLA RP RIGHT VENTRICULAR BYPASS (ASSIST) DEVICE OJE ABIOMED EUROPE, GMBH (GERMANY) IMPELLA RP 1181611 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death