BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA 5.5

    MDR report key: 20159467 · Received September 6, 2024

    Report

    Report Number
    1220648-2024-17554
    Event Type
    Malfunction
    Date Received
    September 6, 2024
    Date of Event
    August 12, 2024
    Report Date
    September 25, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR DELIVERY ISSUES HAS BEEN COMPLETED. THE IMPELLA DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF DELIVERY ISSUE IS DETERMINED TO BE PATIENT CONDITION BECAUSE THE LV ANATOMY NOT CONDUCIVE TO OPTIMAL SUPPORT ON IMPELLA CAUSING TO ABORT THE IMPLANTATION. E4 SHOULD HAVE BEEN LEFT BLANK ON MANUFACTURER DEVICE REPORT 1220648-2024-17554.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS DISCARDED BY THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.   IMPELLA 5.5 WITH SMARTASSIST FOR USE DURING CARDIOGENIC SHOCK 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)¿ SECTION: WARNINGS & CAUTIONS: WARNINGS ¿TO REDUCE THE RISK OF CARDIAC OR VASCULAR INJURY (INCLUDING PERFORATION) WHEN MANIPULATING THE HEART DURING CARDIAC SURGERY, EVALUATE THE POSITION OF THE PUMP USING IMAGING GUIDANCE PRIOR TO MANIPULATING THE HEART, AND MONITOR POSITION. [ADDITION FOR 5.0, 5.5 ONLY] IN INSTANCES WHERE THE IMPELLA PUMP HAS BEEN PLACED PRIOR TO PERFORMING CARDIAC SURGERY WITH AORTIC CROSS CLAMPING AND CARDIOPLEGIC ARREST, CARE SHOULD BE TAKEN WHEN MANIPULATING THE HEART WHEN THE PUMP POSITION IS FIXED WITH APPLICATION OF THE AORTIC CROSS CLAMP ACROSS THE PUMP CATHETER.¿ ¿TO REDUCE THE RISK OF CARDIAC OR VASCULAR INJURY (INCLUDING VENTRICULAR PERFORATION) WHEN ADVANCING OR TORQUING THE IMPELLA, ADJUSTMENTS SHOULD BE PERFORMED UNDER IMAGING GUIDANCE. SECTION: WARNINGS & CAUTIONS: WARNINGS SECTION: PRE-SUPPORT EVALUATION SECTION: AXILLARY INSERTION OF THE IMPELLA 5.5 CATHETER SECTION: DIRECT AORTIC INSERTION SECTION: USE OF IMPELLA WITH TRANSCATHETER AORTIC VALVES ¿TO REDUCE THE RISK OF CARDIAC INJURY (INCLUDING VENTRICULAR PERFORATION), PHYSICIANS SHOULD EXERCISE SPECIAL CARE WHEN INSERTING THE IMPELLA CATHETER IN PATIENTS WITH COMPLEX ANATOMY. THIS INCLUDES PATIENTS WITH KNOWN OR SUSPECTED DECREASED VENTRICULAR CAVITY SIZE, VENTRICULAR ANEURYSMS, CONGENITAL HEART DISEASE, OR COMPROMISED CARDIAC TISSUE QUALITY IN THE SETTINGS OF ACUTE INFARCTION WITH TISSUE NECROSIS.¿ ¿TO REDUCE THE RISK OF VASCULAR INJURY, PHYSICIANS SHOULD EXERCISE CAUTION WHEN INSERTING THE IMPELLA CATHETER IN PATIENTS WITH COMPLEX PERIPHERAL VASCULAR ANATOMY. THIS INCLUDES PATIENTS WITH KNOWN OR SUSPECTED: UNREPAIRED ABDOMINAL AORTIC ANEURYSM, SIGNIFICANT DESCENDING THORACIC AORTIC ANEURYSM, DISSECTION OF THE ASCENDING/ TRANSVERSE/DESCENDING AORTA, CHRONIC ANATOMICAL CHANGES IN THE RELATIONSHIP OF THE AORTA/AORTIC VALVE/VENTRICULAR ALIGNMENT, SIGNIFICANT MOBILE ATHEROMATOUS DISEASE IN THE THORACIC OR ABDOMINAL AORTA OR PERIPHERAL VESSELS.¿ ¿PHYSICIANS SHOULD EXERCISE SPECIAL CARE WHEN INSERTING THE IMPELLA CATHETER DURING ACTIVE CARDIOPULMONARY RESUSCITATION (CPR). IN ADDITION, ACTIVE CPR MANEUVERS MAY CHANGE THE POSITION OF THE IMPELLA DEVICE, INTRODUCING A RISK OF CARDIAC OR VASCULAR INJURY (INCLUDING VENTRICULAR PERFORATION). CHECK THAT THE PUMP IS POSITIONED CORRECTLY IN THE LEFT VENTRICLE AFTER CPR WITH ECHOCARDIOGRAPHY GUIDANCE.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT THE PATIENT WAS EVALUATED FOR IMPELLA 5.5 PLACEMENT AND DETERMINED LEFT VENTRICLE (LV) HYPERTROPHY WOULD PREVENT OPTIMAL SUPPORT FROM IMPELLA. THE PROCEDURE WAS ABORTED DUE TO THE LV ANATOMY. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1343757 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2025503438 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Female