BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP

    MDR report key: 20058852 · Received August 24, 2024

    Report

    Report Number
    1220648-2024-16495
    Event Type
    Death
    Date Received
    August 24, 2024
    Date of Event
    June 15, 2021
    Report Date
    August 24, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED. THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS. AS NOTED IN THE IMPELLA IFU: IMPELLA CP WITH SMARTASSIST SYSTEM (VASCULAR DISSECTION). SECTION: WARNINGS & CAUTIONS: CAUTIONS ¿PHYSICIANS SHOULD EXERCISE SPECIAL CARE WHEN INSERTING THE IMPELLA CATHETER IN PATIENTS WITH KNOWN OR SUSPECTED UNREPAIRED ABDOMINAL AORTIC ANEURYSM OR SIGNIFICANT DESCENDING THORACIC AORTIC ANEURYSM OR DISSECTION OF THE ASCENDING, TRANSVERSE, OR DESCENDING AORTA.¿ CAUTION: ¿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 THE RISK OF CARDIAC OR VASCULAR INJURY (INCLUDING VENTRICULAR PERFORATION). CHECK THAT THE PUMP IS POSITIONED CORRECTLY AFTER CPR WITH CHEST X-RAY 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 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.¿ ¿TO REDUCE THE RISK OF CARDIAC OR VASCULAR 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, THIN-WALLED VENTRICLES DUE TO CHRONIC DILATION, CONGENITAL HEART DISEASE, OR COMPROMISED CARDIAC TISSUE QUALITY.¿ ¿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.¿ AS NOTED IN THE IMPELLA IFU: IMPELLA CP WITH SMARTASSIST SYSTEM (DELIVERY ISSUES). 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. 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. SECTION: WARNINGS & CAUTIONS: CAUTIONS. ¿DILATORS AND CATHETERS SHOULD BE REMOVED SLOWLY FROM THE SHEATH. RAPID REMOVAL MAY DAMAGE THE VALVE, RESULTING IN BLOOD FLOW THROUGH THE VALVE.¿ 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.¿ ¿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.¿ 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 OR VASCULAR 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, THIN-WALLED VENTRICLES DUE TO CHRONIC DILATION, CONGENITAL HEART DISEASE, OR COMPROMISED CARDIAC TISSUE QUALITY.¿ ¿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. ¿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 THE RISK OF CARDIAC OR VASCULAR INJURY (INCLUDING VENTRICULAR PERFORATION). CHECK THAT THE PUMP IS POSITIONED CORRECTLY AFTER CPR WITH CHEST X-RAY 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 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.¿ ¿TO REDUCE THE RISK OF CARDIAC OR VASCULAR 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, THIN-WALLED VENTRICLES DUE TO CHRONIC DILATION, CONGENITAL HEART DISEASE, OR COMPROMISED CARDIAC TISSUE QUALITY.¿ ¿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. ¿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 THE RISK OF CARDIAC OR VASCULAR INJURY (INCLUDING VENTRICULAR PERFORATION). CHECK THAT THE PUMP IS POSITIONED CORRECTLY AFTER CPR WITH CHEST X-RAY GUIDANCE.¿

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT INOTED WITH POSTCARDIOTOMY CARDIOGENIC SHOCK (PCCS)/LOW CARDIAC OUTPUT SYNDROME (LCOS) WAS ATTEMPTED TO BE IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. MULTIPLE ATTEMPTS AT ADVANCING THE IMPELLA CP ACROSS THE AORTIC VALVE WERE UNSUCCESSFUL. ADDITIONALLY, THE PATIENT HAD A MASSIVE GASTROINTESTINAL (GI) BLEED, THEREFORE, DEVICE IMPLANT WAS ABORTED. FURTHER INFORMATION NOTED SURVIVAL OUTCOME AT EXPLANTED INDICATED THE PATIENT EXPIRED. MEDICAL SAFETY REVIEW OF THE EVENT NOTED THERE IS NOT HAVE ENOUGH INFORMATION TO EXCLUDE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275958 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2022068392 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Death