BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA 5.5 WITH SMARTASSIST S2 SET, US

    MDR report key: 24483736 · Received March 2, 2026

    Report

    Report Number
    1220648-2026-04328
    Event Type
    Death
    Date Received
    March 2, 2026
    Date of Event
    February 19, 2026
    Report Date
    March 2, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    PPAE (MAJOR BLEED): THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    A 59-YEAR-OLD FEMALE PATIENT WITH POSTCARDIOTOMY CARDIOGENIC SHOCK (PCCS), PRESENTING IN SCAI STAGED SHOCK, UNDERWENT DIRECT AORTIC SURGICAL PLACEMENT OF AN IMPELLA 5.5 ON (B)(6) 2026 AT 19:15 AND EXPIRED SHORTLY AFTER EXPLANT AT 20:12 THE SAME EVENING. THE PATIENT HAD BEEN ON CARDIOPULMONARY BYPASS SINCE 08:00 AND EXPERIENCED SEVERE, DIFFUSE BLEEDING THROUGHOUT THE CASE, DESCRIBED AS HEMORRHAGE FROM MULTIPLE TISSUE PLANES INCLUDING THE ABDOMEN AND LUNGS, WITH TISSUE NOTED TO BE EXTREMELY FRAGILE AND CALCIFIED. A TOTAL OF 14 UNITS OF PRBCS AND 10¿L OF CRYSTALLOIDS WERE ADMINISTERED, AND THE HOSPITAL EXHAUSTED ITS SUPPLY OF FRESH FROZEN PLASMA (FFP). NO EEG ACTIVITY WAS OBSERVED FOR AN EXTENDED PERIOD TOWARD THE END OF THE CASE. THE IMPELLA 5.5 WAS PLACED DIRECTLY VIA GRAFT WITHOUT ANY PROCEDURAL DIFFICULTY, AND THE IMPLANTING SURGEON REPORTED ZERO CONCERNS THAT THE BLEEDING, DEATH, OR ANY ADVERSE EVENTS WERE RELATED TO THE IMPELLA DEVICE, WITH NO ALLEGATIONS MADE AGAINST DEVICE PERFORMANCE. NO PRODUCT WAS RETURNED FOR EVALUATION, AND NO DATA DOWNLOAD WAS REQUIRED. BASED ON THE AVAILABLE INFORMATION, THE OVERWHELMING INTRAOPERATIVE BLEEDING AND SUBSEQUENT DEATH ARE MOST CONSISTENT WITH THE PATIENT¿S PROFOUND UNDERLYING CLINICAL CONDITION AND TISSUE FRAGILITY RATHER THAN AN IMPELLA 5.5 MALFUNCTION. NO EVIDENCE SUGGESTS THAT THE DEVICE CONTRIBUTED TO THE ADVERSE OUTCOME. THE DEATH IS CONSERVATIVELY BEING REPORTED ON THE IMPELLA 5.5 BUT IS UNLIKELY A CONTRIBUTING FACTOR TO THE CAUSE OF DEATH AND IS MORE LIKELY DUE TO THE PATIENT¿S DECLINING CLINICAL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346212 IMPELLA 5.5 WITH SMARTASSIST S2 SET, US TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 IMPELLA 5.5 WITH SMARTASSIST S2 SET, US 2025587327 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Death| R