BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24408409 · Received February 20, 2026

    Report

    Report Number
    1220648-2026-03719
    Event Type
    Death
    Date Received
    February 20, 2026
    Date of Event
    November 6, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER; THEREFORE, AN INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED. RELATED MEDICAL DEVICE REPORTS: THIS IS ONE OF TWO DEVICES ASSOCIATED WITH THE EVENT. REFER TO THE RELATED MANUFACTURER REPORT NUMBER(S) AS NOTED IN SECTION H10.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION HAS BEEN PROVIDED IN D1. PPAE (PAROXYSMAL ATRIAL FIBRILLATION/MAJOR BLEED/RESPIRATORY FAILURE): THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Additional Manufacturer Narrative · 0

    D4 CATALOG NUMBER AND D4 SERIAL NUMBER WERE UPDATED, CORRECTED ACCORDINGLY. NOTE: INVESTIGATION OUTCOME OF THE EVENT REMAINS UNCHANGED.

    Description of Event or Problem · 0

    A 64-YEAR-OLD MALE WITH A SIGNIFICANT PAST MEDICAL HISTORY OF HYPERTENSION, FORMER TOBACCO USE, AND GASTROESOPHAGEAL REFLUX DISEASE (GERD) EXPERIENCED CARDIAC ARREST AT HOME AND WAS SUBSEQUENTLY ADMITTED TO A CARDIAC CATHETERIZATION LABORATORY. CORONARY ANGIOGRAPHY DEMONSTRATED MULTIVESSEL CORONARY ARTERY DISEASE. CARDIOTHORACIC SURGERY WAS CONSULTED, AND THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR FURTHER EVALUATION. DURING HOSPITALIZATION, THE PATIENT DEVELOPED INCREASED WORK OF BREATHING AND REQUIRED REINTUBATION AND WAS THEN TRANSFERRED TO A TERTIARY CARE FACILITY FOR PLACEMENT OF AN IMPELLA CP FOR MECHANICAL CIRCULATORY SUPPORT. AT THE TIME OF IMPLANTATION, THE PATIENT WAS CLASSIFIED AS SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) STAGE E CARDIOGENIC SHOCK. THE IMPELLA CP WAS INSERTED WITHOUT REPORTED DIFFICULTY. TWO PERCLOSE DEVICES WERE DEPLOYED PRIOR TO IMPELLA SHEATH INSERTION FOR VASCULAR CLOSURE PREPARATION. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) POST-PROCEDURE. FOLLOWING PLACEMENT OF A FOLEY CATHETER, URINE WAS NOTED TO BE DARK WITH VISIBLE BLOOD CLOTS. FOLEY IRRIGATION YIELDED LARGE CLOTS DESCRIBED AS APPEARING CONSISTENT WITH OLD BLOOD PER THE NURSING STAFF. LABS WERE OBTAINED AND DID NOT DEMONSTRATE EVIDENCE OF HEMOLYSIS. TWO DAYS AFTER INITIATION OF IMPELLA CP SUPPORT, THE PATIENT UNDERWENT AGGRESSIVE DEEP SUCTIONING BY RESPIRATORY THERAPY, AFTER WHICH THE PATIENT ASPIRATED AND EXPERIENCED OXYGEN DESATURATION INTO THE 70 PERCENT RANGE. EMERGENT BRONCHOSCOPY WAS PERFORMED. MECHANICAL VENTILATION SETTINGS WERE INCREASED. THE PATIENT SUBSEQUENTLY DEVELOPED TACHYCARDIA AND HYPOTENSION WITH ELEVATED PULMONARY ARTERY PRESSURES. EPOPROSTENOL (VELETRI) AND NOREPINEPHRINE (LEVOPHED) WERE INITIATED FOR HEMODYNAMIC SUPPORT. THE PATIENT WAS MEDICALLY PARALYZED. WHITE BLOOD CELL COUNT WAS 21.5. THE PATIENT HAD BEEN FEBRILE THE PRIOR NIGHT BUT WAS AFEBRILE THE NEXT MORNING. THE FOLLOWING DAY, MECHANICAL CIRCULATORY SUPPORT WAS ESCALATED TO AN IMPELLA 5.5 FOR CONTINUED HEMODYNAMIC SUPPORT. AFTER APPROXIMATELY NINE DAYS ON IMPELLA 5.5 SUPPORT, THE PATIENT DEVELOPED ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE AND WAS TREATED WITH AMIODARONE. DESPITE IMPELLA SUPPORT, THE PATIENT¿S CONDITION REMAINED A CONCERN BY THE FAMILY. TWO DAYS LATER, THE PATIENT EXPIRED FOLLOWING WITHDRAWAL OF CARE. TACHYCARDIA, HYPOTENSION, AND FEVER OCCURRING DURING IMPELLA CP SUPPORT ARE BEING REPORTED AS SERIOUS INJURY EVENTS. THE IMPELLA 5.5 IS BEING ASSOCIATED WITH THE DEATH AS IT WAS IN PLACE AT THE TIME OF DEMISE AND THE PATIENT EXPERIENCED ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE REQUIRING ANTIARRHYTHMIC THERAPY WHILE ON SUPPORT. HOWEVER, THE PATIENT'S UNDERLYING CONDITION CONTRIBUTED MOST TO THE DEMISE OUTCOME (INCLUDING SCAI STAGE E CARDIOGENIC SHOCK AND SEVERE CORONARY ARTERY DISEASE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376345 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. 2026738763

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention| D