BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP

    MDR report key: 23895882 · Received December 26, 2025

    Report

    Report Number
    1220648-2025-49435
    Event Type
    Death
    Date Received
    December 26, 2025
    Date of Event
    September 12, 2025
    Report Date
    November 19, 2025
    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
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL SAFETY/CLINICAL REVIEWED THE EVENT. AN 81-YEAR-OLD PATIENT WITH AN ACUTE MYOCARDIAL INFARCTION WAS SUPPORTED WITH AN IMPELLA CP FOR MECHANICAL CIRCULATORY SUPPORT. A DECISION WAS MADE TO ESCALATE SUPPORT TO AN IMPELLA 5.5; HOWEVER, ADVANCEMENT OF THE DEVICE WAS UNSUCCESSFUL DUE TO INABILITY TO PASS THE ANASTOMOSIS, AND THE IMPELLA 5.5 IMPLANTATION WAS ABORTED. AN ANGIOGRAM WAS INITIALLY REPORTED AS SHOWING NO DISSECTION; HOWEVER, SUBSEQUENT DOCUMENTATION CONFIRMED THE PRESENCE OF A VASCULAR DISSECTION, WHICH WAS SUCCESSFULLY REPAIRED. THIS EVENT IS CONSIDERED A SERIOUS INJURY ATTRIBUTED TO THE IMPELLA 5.5. THE PATIENT WAS RETURNED TO IMPELLA CP SUPPORT. THEREAFTER, THE PATIENT DEVELOPED THIRD-DEGREE HEART BLOCK REQUIRING PACING. HEMOLYSIS WAS INITIALLY NOTED BUT LATER RESOLVED, WITH URINE REPORTED AS CLEAR FOR SEVERAL DAYS. ONGOING SUCTION ALARMS AND ¿IMPELLA IN VENTRICLE¿ ALARMS WERE REPORTED DESPITE VOLUME RESUSCITATION AND REPOSITIONING ATTEMPTS. ECHOCARDIOGRAPHY DEMONSTRATED THE PUMP POSITIONED ACROSS THE AORTIC VALVE AND FREE FROM CARDIAC STRUCTURES. A LOSS-OF-FLOW EVENT OCCURRED, RESULTING IN HEMODYNAMIC DECOMPENSATION AND THE NEED FOR INTUBATION. FOLLOWING INTUBATION, DEVICE ALARMS RESOLVED AND FLOWS IMPROVED, ALLOWING FOR TRANSIENT STABILIZATION. PER THE TREATING PHYSICIAN, THE CAUSE OF THE CONTINUOUS SUCTION, LOSS OF FLOW, AND ERRONEOUS PLACEMENT ALARMS WAS UNCLEAR. LATER THIS SAME DAY, THE FAMILY ELECTED TO WITHDRAW LIFE-SUSTAINING CARE, AND THE PATIENT EXPIRED. THE PATIENT¿S UNDERLYING CONDITION AND DISEASE SEVERITY CONTRIBUTED MOST TO THE DEMISE OUTCOME. THE EVENT STORY INVOLVED TWO PRODUCT COMPLAINTS. IMPELLA 5.5 IS A SERIOUS INJURY, AND THE IMPELLA CP IS A DEATH TYPE OF REPORTABLE EVENT. H6: INVESTIGATION TYPE/FINDING/CONCLUSION REMAINS UNCHANGED. 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

    A4 IS UNKNOWN. THE CAUSE OF THE HEMOLYSIS COULD NOT BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS AND NO PRODUCT RETURNED. THE CAUSE OF THE SUCTION AND LOW FLOW WAS MOST LIKELY BIOMATERIAL INGESTION, AS THE CONDITIONS DIDN'T RESOLVE WITH VOLUME REPLETION OR REPOSITIONING, AND DATA LOGS SHOW AN MC SPIKE AND SPEED DEVIATION. THE CAUSE OF THE POSITIONING ISSUES AND ALARMS WAS MOST LIKELY BIOMATERIAL INGESTION, AS THE POSITION WAS CONFIRMED VIA ECHO, AND DATA LOGS SHOW AN MC SPIKE OCCURRING JUST BEFORE THE ALARMS STARTED BUT AN AORTIC PRESSURE WAVEFORM. THE PUMP PASSED ALL POST STERILE INSPECTION CRITERIA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN IMPELLA CP EXPERIENCED A THIRD-DEGREE HEART BLOCK REQUIRING PACING, AND HEMOLYSIS. THE PUMP GENERATED SUCTION ALARMS AND IMPELLA IN VENTRICLE ALARMS. VOLUME WAS GIVEN. THE PUMP POSITION WAS VERIFIED TO BE FREE FROM STRUCTURES. THE LOSS OF FLOW CAUSED THE PATIENT TO DECOMPENSATE AND REQUIRE INTUBATION. ONCE THE PATIENT WAS INTUBATED THE ALARMS RESOLVED AND FLOWS IMPROVED. HOWEVER, THE PATIENT EXPIRED ON IMPELLA SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2403851 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026729413 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Death| R