BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 25174138 · Received May 14, 2026

    Report

    Report Number
    1220648-2026-07838
    Event Type
    Death
    Date Received
    May 14, 2026
    Date of Event
    May 6, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS DISCARDED. THIS IS ONE OF TWO RELATED REPORTS. THIS REPORT REPRESENTS THE SECOND IMPELLA CP USED AND ANOTHER REPORT WAS SUBMITTED TO REPRESENT THE FIRST IMPELLA CP USED. 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

    H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION AND ADDED CLINICAL REVIEW. CORRECTED INFORMATION HAS BEEN PROVIDED IN D3( MANUFACTURER FAX) UPON REVIEW, IT WAS IDENTIFIED THAT THE INFORMATION WAS INADVERTENTLY NOT SUBMITTED IN THE INITIAL REPORT. THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. THE CAUSE OF THE BLEEDING AT THE ACCESS SITE WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY TO REPLACE A PRIOR CP PUMP THAT HAD MALFUNCTIONED. THE CP WAS BEING PLACED FOR THE 85 YEAR OLD FEMALE WHO HAD BEEN ADMITTED IN WITH KNOWN CORONARY ARTERY DISEASE AND PLAN FOR A PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PCI). SHE PRESENTED IN SCAI STAGE E AND NO OTHER MEDICAL HISTORY WAS SHARED. THE CP ALLOWED FOR THE PCI BUT, WHEN THE TEAM DETERMINED THERE WAS LIMB ISCHEMIA, THE PUMP WAS EXPLANTED ON THE DAY OF INSERTION. THE PATIENT HAD COMPLAINED OF LIMB DISCOMFORT THOUGH DOPPLER PULSES WERE INTACT THROUGHOUT. THE CREATINE KINASE (CK) WAS ELEVATED AND TEAM DECIDED PUMP EXPLANT WAS NECESSARY, AND AFTER EXPLANT THE TEAM APPLIED MANUAL PRESSURE AND THEN FEMSTOP. WHEN THE TEAM RELEASED AND REMOVED THE FEMSTOP THERE WAS EXTENSIVE HEMORRHAGE AND A LARGE HEMATOMA DEVELOPED. TO TREAT THEY INITIATED MASSIVE TRANSFUSION PROTOCOL AND GAVE 6 UNITS OF BLOOD DUE TO HEMOGLOBIN DROPPING TO 4.8G/DL. VASPORESSOR MEDICAL MANAGEMENT WAS REQUIRED AS WELL DUE TO HYPOTENSION. LATER IN THE DAY THE DECISION WAS MADE TO WITHDRAW CARE/MAKE HER A DNR AND THE PATIENT EXPIRED. THE DEATH/CARE WITHDRAWAL IS BEING REPORTED ALTHOUGH AN UNLIKELY CONTRIBUTING FACTOR TO THE DEATH, AND MORE LIKELY THE PATIENT'S PRESENTING NATIVE CRITICAL CONDITION OF SCAI STAGE E SHOCK AND TEAM DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547829 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027879508 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1