BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP

    MDR report key: 18934266 · Received March 19, 2024

    Report

    Report Number
    1220648-2024-08273
    Event Type
    Death
    Date Received
    March 19, 2024
    Date of Event
    July 24, 2022
    Report Date
    April 22, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    04260113630280
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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: ¿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 VASCULAR INJURY.¿ ¿ASSESS ACCESS SITE FOR BLEEDING AND HEMATOMA.¿ ¿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.¿ THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

    Additional Manufacturer Narrative · 0

    MEDICAL SAFETY REVIEW OF THE EVENT NOTED THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE. CORRECTED INFORMATION FOR THE INITIAL MFR 1220648-2024-08273 WAS PROVIDED IN SECTIONS B2, B5, D6, H1, AND H6.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE REPORTED ISSUE HAS BEEN COMPLETED. DUE TO THE LIMITED CLINICAL INFORMATION AND LACK OF AVAILABLE DATA/PRODUCT THE ROOT CAUSE OF THIS INVESTIGATION IS NOT DETERMINED. THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A 78-YEAR-OLD FEMALE IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. WHILE ON SUPPORT, THE PATIENT HAD BLEEDING AT THE ACCESS SITE AND ALSO EXPERIENCED VENTRICULAR TACHYCARDIA AND SINUS TACHYCARDIA ELEVATED MYOCARDIAL INFRACTION. CORRECT POSITION OF IMPELLA CP WAS VERIFIED VIA TRANS-THORACIC ECHO. THE IMPELLA CP WAS EXPLANTED.

    Description of Event or Problem · 0

    DISCONTINUED THERAPY AFTER DISCUSSION WITH FAMILY, PATIENT GOT VISIBLY WORSE AND JUST PASSED AWAY. MEDICAL SAFETY REVIEW OF THE EVENT NOTED THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2562854 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2023204977 04260113630280

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention| D