BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA CP

    MDR report key: 22936863 · Received September 2, 2025

    Report

    Report Number
    1220648-2025-45957
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    July 31, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011609
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: IMPELLA CP RETURNED FOR EVALUATION. LOW PUMP FLOW/SUCTION: CLINICAL DETAILS REPORT THAT A VSP PROCEDURE WAS DONE ON (B)(6) 2025. DURING THE PROCEDURE, THE PUMP CANNULA HAD TO BE CLAMPED AND MOVED. ONCE THE PROCEDURE WAS COMPLETED, THE CLAMP WAS REMOVED, THE PUMP WAS BROUGHT BACK TO APPROPRIATE POSITION, AND THE PUMP WAS TAKEN OUT OF SURGICAL MODE, BUT FLOWS WERE LOW AND SUCTION ALARMS BEGAN TO TRIGGER. ATTEMPTS TO REPOSITION THE PUMP WERE MADE, BUT THE ISSUE PERSISTED, SO THE PUMP WAS EXPLANTED. DATA LOGS WERE REVIEWED, AND THE REPORTED ISSUE WAS CONFIRMED. AFTER THE PUMP CAME OUT OF SURGICAL MODE AT THE END OF THE CASE, THERE WERE A NUMBER OF SUCTION ALARM #73 TRIGGERS, INDICATING LOW MC VALUES FOR THE P-LEVEL. FLOWS WERE NEVER ABLE TO GET HIGHER THAN 0.5 L/MIN EITHER. THE RT LOG ALSO SHOWED MC MODULATION AND VALUES TO BE QUITE LOW. THERE WERE NO INDICATIONS OF ABNORMAL SPIKES. PRODUCT WAS RETURNED WITH A CUT IN THE CATHETER, AND ONLY THE MOTOR HOUSING SIDE WAS RETURNED. THERE WAS NO DAMAGE TO THE IMPELLER, BUT THERE WAS EVIDENCE OF TWO SEPARATE KINKS IN THE CANNULA AS WELL AS A SMALL AMOUNT OF BIOMATERIAL NEAR THE IMPELLER. THE PUMP WAS UNABLE TO BE RUN TO ATTEMPT TO REPRODUCE LOW FLOWS BECAUSE OF THE CUT IN THE CATHETER. BASED ON THE REPORT IN CLINICAL DETAILS THAT THE CANNULA WAS CLAMPED JUST PRIOR TO THE LOW FLOWS, AND RETURNED PRODUCT HAD EVIDENCE OF SEVERAL KINKS IN THE CANNULA, THE CAUSE OF THE LOW PUMP FLOWS WAS DETERMINED TO BE A CANNULA KINK. THE FINDING OF BIOMATERIAL ON RETURNED PRODUCT COULD POTENTIALLY HAVE BEEN A DOWNSTREAM EFFECT OF THE CANNULA KINK, HOWEVER, UNABLE TO BE RELATED TO LOW FLOWS SINCE THERE WERE NO INDICATIONS OF BIOMATERIAL INGESTION IN DATA LOGS. DEVICE HISTORY LOT: DEVICE LOT: 1893775. DEVICE HISTORY BATCH: SUBCOMPONENT: NA. DEVICE HISTORY REVIEW: PUMP SN (B)(6) PASSED ALL POST-STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    A.2, A.3, AND A.4 ARE UNKNOWN. THE IMPELLA DEVICE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL REPORT WILL BE FILED. REFER TO SECTION H.10 FOR THE RELATED REPORT THAT REPRESENTS THE AUTOMATED IMPELLA CONTROLLER.

    Additional Manufacturer Narrative · 0

    B5 ADDITIONAL EVENT INFORMATION RECEIVED. H6 CODES UPDATED.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT FOLLOWING A SCHEDULED PROCEDURE, THE FLOW RATE OF AN IMPLANTED IMPELLA CP PUMP COULD NOT BE INCREASED. IT WAS NOTED THAT THE PUMP HAD BEEN PLACED IN SURGICAL MODE DURING THE PROCEDURE AND THE CANNULA HAD BEEN CLAMPED WITH A BLOCKING FORCEP TO ADDRESS A LACK OF INCREASE IN BASE PRESSURE. UPON RELEASE AND CANCELLATION OF SURGICAL MODE, THE AUXILIARY FLOW RATE FAILED TO INCREASE AND SUCTION ALARMS APPEARED. DESPITE REPOSITIONING THE PUMP, THE ISSUE PERSISTED AND THE DECISION WAS MADE TO REMOVE THE DEVICE. AN INTRA-AORTIC BALLOON PUMP WAS PLACED AND THE PATIENT REMAINED SUPPORTED VIA EXTRACORPOREAL MEMBRANE OXYGENATION.

    Description of Event or Problem · 0

    THE PRODUCT WAS USED IN SURGICAL MODE DURING A VSP OPERATION. TO ADDRESS THE PROBLEM OF A FAILURE TO INCREASE BASE PRESSURE, THE PUMP POSITION WAS CHANGED SEVERAL TIMES DURING THE OPERATION, AND THE SHAFT AND CANNULA WERE CLAMPED WITH A BLOCKING FORCEPS. AFTER TREATMENT, THE PUMP WAS RETURNED TO ITS PROPER POSITION, SURGICAL MODE WAS DEACTIVATED, AND THE SUPPORT LEVEL WAS INCREASED. HOWEVER, THE SUPPORT FLOW RATE DID NOT INCREASE, AND A SUCTION ALERT OCCURRED AT APPROXIMATELY 0.1. FURTHER ADJUSTMENTS TO THE PUMP POSITION DID NOT RESULT IN AN ADEQUATE FLOW RATE OR ABATEMENT OF SUCTION. THEREFORE, THE CP WAS REMOVED AND REPLACED WITH AN IABP. THE PATIENT RETURNED TO THE ROOM WITH ECMO AND IABP SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152764 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026660287 00813502011609

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown