BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA RP

    MDR report key: 19244808 · Received May 4, 2024

    Report

    Report Number
    1220648-2024-10755
    Event Type
    Malfunction
    Date Received
    May 4, 2024
    Date of Event
    April 27, 2024
    Report Date
    June 21, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    PYX
    UDI-DI
    00813502012811
    PMA / PMN Number
    P170011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS DISCARDED BY THE CUSTOMER, AND THEREFORE, AN EVALUATION OF THE DEVICE WAS NOT POSSIBLE. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL MDR WILL BE FILED. INSTRUCTIONS FOR USE FOR THE RELATED EVENT ARE AS FOLLOWS: ¿UNRESOLVED PURGE PRESSURE HIGH ALARM IF NOT RESOLVED BY THE RECOMMENDATIONS PROVIDED, HIGH PURGE PRESSURE¿WHICH TRIGGERS THE ¿PURGE PRESSURE HIGH¿ ALARM MESSAGE¿COULD BE AN INDICATION OF A KINK IN THE IMPELLA RP WITH SMARTASSIST SYSTEM CATHETER. IN THIS CASE, THE MOTOR IS NO LONGER BEING PURGED AND MAY EVENTUALLY STOP. MONITOR MOTOR CURRENT AND CONSIDER REPLACING THE IMPELLA RP WITH SMARTASSIST SYSTEM CATHETER WHENEVER A RISE IN MOTOR CURRENT IS SEEN.¿

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE REPORTED LOW PUMP FLOW, HIGH PURGE PRESSURE, AND ACCESS SITE BLEED HAS BEEN COMPLETED. THE PUMP WAS RETURNED FOR EVALUATION. NO CANNULA OR CATHETER KINKS WERE OBSERVED. NO BIOMATERIAL WAS FOUND AROUND THE IMPELLER OR PURGE GAP. THE LOW PUMP FLOW AND HIGH PURGE PRESSURE WERE NOT REPRODUCED WHEN RUNNING WITH THE RETURNED PURGE CASSETTE AT P-9. CLINICAL DETAILS STATED THAT REPOSITIONING THE PUMP DID NOT RESOLVE THE LOW FLOW AND HIGH PURGE PRESSURE ISSUES. CLINICAL MENTIONS THAT ACT WAS NOT MAINTAINED. DATA LOGS SHOW 25 HOURS INTO SUPPORT THERE IS A MOTOR CURRENT (MC) SPIKE, UPWARDS PS SHIFT, SPEED DEVIATION AND DROP IN FLOWS. THE PURGE PRESSURE IMMEDIATELY BEGINS TO RISE WITH DROP IN PURGE FLOW OVER A SPAN OF ABOUT 2 MINUTES TRIGGERING HPP AND PURGE SYSTEM BLOCKED ALARMS. THE LOW PUMP FLOWS AND HIGH PURGE PRESSURE DO NOT RESOLVE. THE ROOT CAUSE OF THE LOW PUMP FLOW ISSUE WAS MOST LIKELY BIOMATERIAL. THE ROOT CAUSE OF THE HIGH PURGE PRESSURE ISSUE WAS MOST LIKELY BIOMATERIAL. THE ROOT CAUSE OF THE ACCESS SITE BLEEDING - MINOR ISSUE WAS NOT DETERMINED SINCE THERE IS A LACK OF CLINICAL DETAILS. THE INSTRUCTIONS FOR USE REFERENCED IN THE INITIAL REPORT IS FOR THE IMPELLA RP WITH SMARTASSIST SYSTEM IN SECTION: USING THE AUTOMATED IMPELLA CONTROLLER WITH THE IMPELLA RP WITH SMARTASSIST SYSTEM CATHETER.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A PATIENT IN POSTCARDIOTOMY CARDIOGENIC SHOCK HAD AN IMPELLA RP FLEX PLACED FOR BIPELLA SUPPORT ALONG WITH THE IMPELLA CP. THERE WAS SUSPECTED CLOT INGESTING IN THE IMPELLA RP PUMP, AND THERE WAS A SPIKE IN MOTOR CURRENT FOLLOWED OBSERVED LOW FLOWS. SIMULTANEOUSLY, PURGE PRESSURE HIGH AND PURGE BLOCK ALARMS PRESENTED. STAT CHEST XRAY SHOWED THE IMPELLA RP PUMP WAS IN SUBOPTIMAL POSITION AND HAD POSSIBLY PULLED BACK WHERE THE OUTFLOW WAS AT THE LEVEL OF THE PULMONIC VALVE OR POSSIBLY IN THE RIGHT VENTRICLE. THE IMPELLA RP FLEX WAS SUCCESSFULLY REPOSITIONED; HOWEVER, THIS DID NOT RESOLVE THE ALARMS OR LOW FLOWS. THE DECISION WAS MADE TO EXPLANT THE IMPELLA RP PUMP. THE IMPELLA RP PUMP WAS EXPLANTED WITHOUT ISSUES AND HEMOSTASIS OBTAINED AT RIGHT INTERNAL JUGULAR BY PURSE STRING SUTURE. IMPELLA CP THERAPY CONTINUED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146120 IMPELLA RP TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. IMPELLA RP 2025478757 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male