BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CPSA C9+ SET, OUS

    MDR report key: 24469279 · Received February 27, 2026

    Report

    Report Number
    1220648-2026-04201
    Event Type
    Death
    Date Received
    February 27, 2026
    Date of Event
    February 19, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502013344
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4 CATALOG, SERIAL NUMBER AND UDI UPDATED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION FROM THE CUSTOMER. 1: NO, THE PUMP WAS NOT EXPLANTED DUE TO THE HIGH PURGE PRESSURE. 2.: NO, CONTRARY OUR COMMUNICATION THE PUMP WAS DISCARDED. 3: I DO NOT HAVE ANY INFORMATION ABOUT THE CAUSE OF DEATH. BUT ACCORDING TO DR. (B)(6) (LEADING PHYSICIAN OF THE INTENSIVE CARE UNIT (ICU), CONVERSATION ON (B)(6)) THERE IS NO RELATION BETWEEN DEATH AND IMPELLA.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS COMPLETED. INVESTIGATION SUMMARY: HEMODYNAMIC INSTABILITY: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. PURGE PRESSURE HIGH: THE CAUSE OF THE PURGE PRESSURE HIGH ISSUE COULD NOT BE DETERMINED WITHOUT THE RETURNED PRODUCT FOR INVESTIGATION AND SUFFICIENT CLINICAL DETAILS, INCLUDING DATA LOGS.

    Additional Manufacturer Narrative · 0

    A5 AND A6 ARE 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.

    Description of Event or Problem · 0

    A 49-YEAR-OLD MALE WAS SUPPORTED WITH AN IMPELLA CP DEVICE FOR THE INDICATION OF ACUTE MYOCARDIAL INFARCTION WITH CARDIOGENIC SHOCK, WITH A PRE SUPPORT CLINICAL STATE CONSISTENT WITH SCAI SHOCK STAGE D. THE DEVICE WAS IMPLANTED PERCUTANEOUSLY VIA THE LEFT FEMORAL ARTERY ON (B)(6) 2026. ON THE MORNING OF (B)(6). 2026, THE AIC DISPLAYED A DECLINE IN PURGE FLOW FROM APPROXIMATELY 12 ML/H TO 8 ML/H, ACCOMPANIED BY A RISE IN PURGE PRESSURE FROM ~350 MMHG TO ~550 MMHG. MOTOR CURRENT ALSO INCREASED. THESE FINDINGS WERE DISCUSSED WITH QUALITY ASSURANCE INCLUDING THE RISK OF PUMP STOPPAGE AND CLINICAL RECOMMENDATIONS. ANTICOAGULATION (PTT) REMAINED WITHIN TARGET RANGE AND WAS HELD ONLY ONCE FOR 3 HOURS. THE PATIENT¿S CARE WAS WITHDRAWN, AND HE EXPIRED ON (B)(6) 2026 AT 7:00 AM, AT WHICH TIME THE IMPELLA CP WAS EXPLANTED. AT PRESENT, THE REPORTED EVENT OF RISING PURGE PRESSURE, REDUCED PURGE FLOW, AND INCREASED MOTOR CURRENT IS CONSISTENT WITH KNOWN POTENTIAL DEVICE BEHAVIORS UNDER CONDITIONS SUCH AS PURGE LINE OBSTRUCTION OR THROMBOTIC BURDEN; HOWEVER, NO DEFINITIVE CAUSE CAN BE DETERMINED WITHOUT DEVICE EVALUATION. PRODUCT RETURN AND SUBSEQUENT ANALYSIS ARE REQUIRED TO CONFIRM WHETHER A DEVICE RELATED MALFUNCTION CONTRIBUTED TO THE OBSERVED PERFORMANCE CHANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269916 IMPELLA CPSA C9+ SET, OUS TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026779058 00813502013344

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Death