BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA RP

    MDR report key: 20201653 · Received September 12, 2024

    Report

    Report Number
    1220648-2024-17679
    Event Type
    Malfunction
    Date Received
    September 12, 2024
    Date of Event
    August 19, 2024
    Report Date
    October 9, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    PYX
    UDI-DI
    00813502012811
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF LOW PUMP FLOW HAS BEEN COMPLETED. THE PRODUCT WAS RETURNED AND EVALUATED. THERE WERE KINKS IN THE CANNULA OBSERVED AND BIOMATERIAL FOUND ON THE IMPELLER. LOW PUMP FLOW WAS NOT REPRODUCED. THE DATA LOGS FROM THE FIELD SHOWED A LARGE MOTOR CURRENT SPIKE ONCE THE PUMP WAS TAKEN OUT OF SURGICAL MODE, WHICH WAS FOLLOWED BY LOW FLOW. THE PLACEMENT SIGNAL INCREASED AND THERE WERE SPEED DEVIATIONS WHILE THE FLOWS DECREASED TO LESS THAN 1L/MIN AT P-8 AND P-9, WHICH SUGGESTS A LARGER BIOMATERIAL INGESTION. THE ROOT CAUSE OF THE LOW PUMP FLOW WAS MOST LIKELY BIOMATERIAL. THE FAILURE MODE THROMBUS WAS REMOVED AND INCORPORATED INTO THE ROOT CAUSE OF THE LOW PUMP FLOW INSTEAD. THE FOLLOWING HAVE BEEN REPORTED INCORRECTLY OR MISSING FROM MANUFACTURER DEVICE REPORT 1220648-2024-17679: B1 CHANGED TO PRODUCT PROBLEM. B2 SHOULD HAVE BEEN LEFT BLANK. E4 SHOULD HAVE BEEN LEFT BLANK. H1 TYPE OF REPORTABLE EVENT. H6 CODE 4440 WAS REPORTED INCORRECTLY. NEW CODE WAS ADDED TO HEALTH EFFECT - CLINICAL CODE.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS RECEIVED FOR EVALUATION. UPON INVESTIGATION COMPLETION, A SUPPLEMENTAL MDR WILL BE FILED. SECTION: POTENTIAL ADVERSE EVENTS (UNITED STATES) ¿ARRHYTHMIA, ATRIAL FIBRILLATION, BLEEDING, CARDIAC TAMPONADE, CARDIOGENIC SHOCK, DEATH, DEVICE MALFUNCTION, HEMOLYSIS, HEPATIC FAILURE, INSERTION SITE INFECTION, PERFORATION, PHLEGMASIA CERULEA DOLENS (A SEVERE FORM OF DEEP VENOUS THROMBOSIS), PULMONARY VALVE INSUFFICIENCY, RESPIRATORY DYSFUNCTION, SEPSIS, THROMBOCYTOPENIA, THROMBOTIC VASCULAR (NON-CENTRAL NERVOUS SYSTEM COMPLICATION, TRICUSPID VALVE INJURY, CARDIAC OR VASCULAR INJURY (INCLUDING VENTRICULAR PERFORATION), VENOUS THROMBOSIS, VENTRICULAR FIBRILLATION AND/OR TACHYCARDIA.¿

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THE 34-YEAR-OLD MALE PATIENT WAS ON IMPELLA RP FLEX SUPPORT WHEN THE FLOWS DROPPED OUTPUT AND FAILED TO PROVIDE ADEQUATE FLOWS TO SUPPORT THE PATIENT. THE PUMP WAS EXPLANTED AND AFTER THE EXPLANT BIOMATERIAL WAS NOTED IN THE INLET AFTER EXPLANT. THE PATIENT OUTCOME AT EXPLANT WAS THAT THEY SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574270 IMPELLA RP TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. IMPELLA RP 2025517778 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male Required Intervention