BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP

    MDR report key: 20955933 · Received December 17, 2024

    Report

    Report Number
    1220648-2024-24870
    Event Type
    Death
    Date Received
    December 17, 2024
    Date of Event
    January 31, 2024
    Report Date
    January 10, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE REPORTED ARRHYTHMIA AND ACCESS SITE BLEED HAS BEEN COMPLETED. NEITHER THE DEVICE NOR SUFFICIENT CLINICAL INFORMATION WAS RETURNED FOR EVALUATION. THE ROOT CAUSE OF ARRHYTHMIA AND ACCESS SITE BLEED COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED NOR SUFFICIENT CLINICAL DETAILS. E.4 SHOULD HAVE BEEN LEFT BLANK ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-24870 AS IT IS UNKNOWN IF THE INITIAL REPORTER ALSO SENT THE REPORT TO THE FOOD AND DRUG ADMINISTRATION. H.6 HEALTH EFFECT - IMPACT CODE 4617 WAS INADVERTENTLY OMITTED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-24870 AND WAS ADDED.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM 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: IMPELLA CP WITH SMART ASSIST SYSTEM SECTION: GENERAL PATIENT CARE CONSIDERATIONS ¿ASSESS ACCESS SITE FOR BLEEDING AND HEMATOMA.¿ SECTION: ENTERING CARDIAC OUTPUT USE OF THE REPOSITIONING SHEATH AND PEEL-AWAY INTRODUCER ¿REMOVE THE PEEL-AWAY INTRODUCER COMPLETELY FROM THE ARTERY OVER THE CATHETER SHAFT TO PREVENT TRAUMA AND SIGNIFICANT BLEEDING AND APPLY MANUAL PRESSURE ABOVE THE PUNCTURE SITE.¿ SECTION: POTENTIAL ADVERSE EVENTS (UNITED STATES). ¿ACUTE RENAL DYSFUNCTION, AORTIC VALVE INJURY, BLEEDING, CARDIOGENIC SHOCK, CEREBRAL VASCULAR ACCIDENT/STROKE, DEATH, HEMOLYSIS, LIMB ISCHEMIA, MYOCARDIAL INFARCTION, RENAL FAILURE, THROMBOCYTOPENIA AND CARDIAC OR VASCULAR INJURY¿ (INCLUDING VENTRICULAR PERFORATION).

    Description of Event or Problem · 0

    A NOTIFICATION WAS RECEIVED FROM ABIOMED¿S LONG-TERM OUTCOME AND QUALITY INDICATOR (LOQI) IMPELLA REGISTRY REGARDING A PATIENT THAT ENDURED WORSENING CARDIOGENIC SHOCK WITH A "REMOTE (UNLIKELY) RELATED" RELATIONSHIP TO THE IMPELLA DEVICE USED AND WOULD LATER EXPIRE.THE IMPELLA CP WAS PLACED IN A PATIENT WITH CARDIOGENIC SHOCK FROM AN ACUTE MYOCARDIAL INFARCTION. THE PATIENT REMAINED INTUBATED, TRANSPORTED TO THE UNIT. THE PATIENT WAS ADDITIONALLY SUPPORTED BY EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). VASCULAR CONSULTATION CONFIRMED BILATERAL PEDAL PULSES. IMPELLA CP WAS TAKEN FROM AUTO TO PERFORMANCE LEVEL P-3 WITH ADEQUATE WAVEFORMS AND FLOW. TWO DAYS LATER, THE PATIENT REMAINED INTUBATED WITHOUT SEDATION, WAS RESPONSIVE TO PAINFUL STIMULI BUT DID NOT FOLLOW COMMANDS. NEUROLOGICAL FUNCTION WAS PLANNED FOR REASSESSMENT THROUGHOUT THE DAY TO DETERMINE CARE GOING FORWARD. IT WAS NOTED THAT THE TEAM PLANNED TO ATTEMPT ECMO WEAN AND REMOVAL THE FOLLOWING DAY WITH IMPELLA IN PLACE IN RIGHT FEMORAL ARTERY. VASCULAR PHYSICIAN WAS AT BEDSIDE EARLY THIS DAY IN THIS MORNING AND DP DOPPLER PULSES WERE HEARD VIA DOPPLER. ANTICOAGULATION WAS NOTED WITHIN THERAPEUTIC GOAL RANGE WITH HEPARIN PURGE AND BIVALIRUDIN DRIP (WITH A PLAN TO HOLD BIVALIRUDIN DURING ECMO DECANNULATION). THE PEEL-AWAY SHEATH SUTURED IN PLACE IN RIGHT GROIN AND GAUZE DRESSING WAS SATURATED WITH FRANK RED BLOOD DOWN THE IMPELLA CATHETER ENDING AT THE PEEL-AWAY/BLUE SUTURE HUB WHICH IS PATIENT¿S KNEE. PER THE NURSE, THE PATIENT'S DRESSING WAS SATURATED SINCE THE DAY PRIOR. THE PHYSICIAN REQUESTED A DRESSING CHANGED, REPLACED IN ORDER TO DETERMINE IF BLEEDING IS NEW. THE OLD GAUZE DRESSING WAS REMOVED, INSERTION SITE CLEANED AND DOWN CATHETER/LEG AND REPLACED GAUZE AND TEGADERM. IT WAS NOTED THERE IS NO ACTIVE BLEEDING NOW AT SUCH TIME. THE PATIENT HAD RECEIVED TWO UNITS OF PACKED RED BLOOD CELL ON PRIOR SHIFT, AND ONE UNIT FINISHED EARLIER THIS DAY. THE PATIENT'S HEMOGLOBIN TRANSFUSION WAS 7.1; HOWEVER, THERE WAS NO CURRENT CONCERN FOR ACTIVE BLEEDING. DAY THREE OF SUPPORT, UPDATES NOTED THE PATIENT WAS NOT DOING GREAT, ECMO WAS DECANNULATED AND SATURATIONS WERE SUFFERING. THE FOLLOWING DAY, NOW DAY FOUR OF SUPPORT, AS REPORTED BY THE REGISTRY, THE PATIENT ENDURED WORSENING CARDIOGENIC SHOCK. THE PATIENT WOULD EVENTUALLY EXPIRE THIS SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227243 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2024423314

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Male Death| R| L