BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24415592 · Received February 23, 2026

    Report

    Report Number
    1220648-2026-03810
    Event Type
    Death
    Date Received
    February 23, 2026
    Date of Event
    February 9, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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

    D1 REVISED BRAND NAME SINCE THE INITIAL REPORT WAS SUBMITTED. ADDITIONAL INFORMATION WAS PROVIDED THAT THE DATE OF DEATH WAS THE SAME AS EXPLANT DATE THEREFORE B2 UPDATED. THE INVESTIGATION WAS COMPLETED AND H6 CODES UPDATED. INVESTIGATION SUMMARY: PPAE (MAJOR BLEED): THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    CLINICAL RATIONALE: THE PATIENT IS A 55-YEAR-OLD FEMALE WITH A HISTORY OF CARDIOMYOPATHY WHO PRESENTED IN A PRE-SUPPORT CLINICAL STATE CONSISTENT WITH SCAI CARDIOGENIC SHOCK STAGE C. AN IMPELLA 5.5 (LOT 508888) WAS SURGICALLY IMPLANTED VIA THE RIGHT AXILLARY/SUBCLAVIAN ARTERY ON (B)(6) 2026 AT 10:25 AM TO PROVIDE HEMODYNAMIC SUPPORT AS PART OF A PRE-OPERATIVE STABILIZATION STRATEGY (¿TUNE-UP¿) PRIOR TO A PLANNED SURGICAL PROCEDURE. THE PATIENT REMAINED ON IMPELLA SUPPORT FOR APPROXIMATELY ONE WEEK WITHOUT REPORTED DEVICE-RELATED COMPLICATIONS. ON (B)(6) 2026, THE PATIENT WAS BROUGHT TO THE OPERATING ROOM FOR SURGERY, WHERE SHE DEVELOPED SEVERE PULMONARY HEMORRHAGING. DESPITE INTERVENTION, THE PATIENT EXPIRED INTRAOPERATIVELY. EXPLANT TIME RECORDED AT (B)(6) 2026 AT 5:04 PM CORRESPONDS TO THE DOCUMENTED TIME OF DEATH. BASED ON AVAILABLE INFORMATION, THE PULMONARY HEMORRHAGE AND SUBSEQUENT DEATH APPEAR UNRELATED TO THE IMPELLA DEVICE OR ITS PERFORMANCE. PRODUCT RETURN IS NOT EXPECTED. THE PATIENT¿S DEATH IS CONSERVATIVELY REPORTED BUT LIKELY UNRELATED TO DEVICE PERFORMANCE BUT RATHER A SURGICAL COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433537 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2025474858 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1