BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24998341 · Received April 27, 2026

    Report

    Report Number
    1220648-2026-07138
    Event Type
    Death
    Date Received
    April 27, 2026
    Date of Event
    April 21, 2026
    Report Date
    May 12, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Removal / Correction Number
    95129
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A6. RACE IS UNKNOWN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ABIOMED INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ABIOMED INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    B1/B2, B5, H1, AND H6 UPDATED TO REFLECT PATIENT DEATH. CORRECTED DATA: D4 UDI UPDATED/CORRECTED. THE INVESTIGATION IS STILL ONGOING.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: THIS REPORT IS BEING SUBMITTED TO CORRECT H9. UPON FURTHER REVIEW, IT WAS DETERMINED THAT THE REPORT WAS INCORRECTLY ASSOCIATED WITH A RECALL. THIS INFORMATION WAS ENTERED IN ERROR, AND WITH CURRENT INFORMATION THE EVENT IS NOT ASSOCIATED WITH ANY RECALL.

    Additional Manufacturer Narrative · 0

    THE PUMP IS AVAILABLE FOR RETURN.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY ACCESS TO SUPPORT THE 57 YEAR OLD MALE PATIENT WHO HAD BEEN ADMITTED IN WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE E SHOCK. PRIOR TO THE PUMP INSERTION THE PATIENT WAS SUPPORTED BY INOTROPES, VASOPRESSORS, AND OXYGEN FOR RESPIRATORY NEEDS. UNDERLYING MEDICAL HISTORY WAS NOT SHARED. THE PUMP WAS PLACED HOWEVER THERE WERE SIGNS OF HEMOLYSIS. THE URINE COLOR HAD CHANGED AND THE LABS WERE HEMOLYZING. THE TEAM PERFORMED ECHO IMAGING TO EVALUATE AND TROUBLESHOOT. THEY OBSERVED THE PUMP TO BE CAUGHT IN THE MITRAL. THEY ATTEMPTED TO REPOSITION AND THE PUMP CROSSED INTO THE AORTA. THE TEAM COULD NOT RECROSS DESPITE ALL EFFORTS AND IN THE UNSUCCESSFUL ATTEMPTS THE PUMP KINKED. THE DECISION WAS MADE TO REMOVE AND REPLACE THE PUMP WITH A NEW IMPELLA CP. THE EXCHANGE WAS PERFORMED WITH NO CLINICAL CONSEQUENCE TO THE PATIENT. PATIENT SURVIVES TO DATE ON NEW PUMP.

    Description of Event or Problem · 0

    AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY ACCESS TO SUPPORT THE 57 YEAR OLD MALE PATIENT WHO HAD BEEN ADMITTED IN WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE E SHOCK. PRIOR TO THE PUMP INSERTION THE PATIENT WAS SUPPORTED BY INOTROPES, VASOPRESSORS, AND OXYGEN FOR RESPIRATORY NEEDS. UNDERLYING MEDICAL HISTORY WAS NOT SHARED. THE PUMP WAS PLACED HOWEVER THERE WERE SIGNS OF HEMOLYSIS. THE URINE COLOR HAD CHANGED AND THE LABS WERE HEMOLYZING. THE TEAM PERFORMED ECHO IMAGING TO EVALUATE AND TROUBLESHOOT. THEY OBSERVED THE PUMP TO BE CAUGHT IN THE MITRAL. THEY ATTEMPTED TO REPOSITION AND THE PUMP CROSSED INTO THE AORTA. THE TEAM COULD NOT RECROSS DESPITE ALL EFFORTS AND IN THE UNSUCCESSFUL ATTEMPTS THE PUMP KINKED. THE DECISION WAS MADE TO REMOVE AND REPLACE THE PUMP WITH A NEW IMPELLA CP. THE EXCHANGE WAS PERFORMED WITH NO CLINICAL CONSEQUENCE TO THE PATIENT. THE 2ND CP PUMP SUPPORTED TIL CARE WAS WITHDRAWN AND PATIENT EXPIRED. THE DEVICE WILL BE CONSERVATIVELY REPORTED FOR DEATH; HOWEVER, THE DEATH IS MOST LIKELY ATTRIBUTED TO THE PATIENT'S UNDERLYING CRITICAL CLINICAL CONDITION AS THEY PRESENTED IN SCAI SHOCK STAGE E AND EXPIRED WHILE SUPPORTED ON A DIFFERENT DEVICE AFTER JUST OVER 3 DAYS OF SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97157 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027863710 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1