BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24561162 · Received March 10, 2026

    Report

    Report Number
    1220648-2026-04924
    Event Type
    Death
    Date Received
    March 10, 2026
    Date of Event
    November 27, 2025
    Report Date
    May 6, 2026
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION: D1 BRAND NAME UPDAED. D4 CATALOG NUMBER AND SERIAL NUMBER UPDATED.

    Additional Manufacturer Narrative · 0

    THE EXACT DATE OF DEATH IS UNKNOWN BUT HAS BEEN CAPTURED AS THE DATE OF EXPLANT. IF ACTUAL INFORMATION BECOMES KNOWN, A SUPPLEMENTAL REPORT WILL BE SUBMITTED AS APPROPRIATE. 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. RELATED MEDICAL DEVICE REPORTS: THIS IS ONE OF THREE DEVICES ASSOCIATED WITH THE EVENT. REFER TO THE RELATED MANUFACTURER REPORT NUMBER(S) AS NOTED IN SECTION H10.

    Description of Event or Problem · 0

    A 47-YEAR-OLD FEMALE PATIENT WAS SKIING AND BECAME UNRESPONSIVE. PRESENTED IN CARDIOGENIC SHOCK. IMPELLA CP INSERTION VIA THE RIGHT FEMORAL ARTERY WAS SUCCESSFUL, HOWEVER THE DEVICE HAD A HIGH PURGE PRESSURE ALARM AND THE PHYSICIAN DECIDED TO EXCHANGE TO A SECOND IMPELLA CP. EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS ADDED, BECOMING THE PRIMARY SUPPORT DEVICE. PATIENT EXPERIENCED VENTRICULAR TACHYCARDIA AND THE PUMP WAS REPOSITIONED. PATIENT TRANSFERRED TO ANOTHER FACILITY FOR CARE ESCALATION. AN AORTIC DISSECTION WAS NOTED, BUT IMAGING REVIEW SHOWED THE DISSECTION WAS PRESENT PRIOR TO INITIAL IMPELLA IMPLANTATION. UNDER CONTINUING ECMO THERAPY, MEDICATIONS WERE INCREASED, AND THE CP WAS REPOSITIONED. IMPELLA CP WAS ESCALATED TO IMPELLA 5.5. ON THE FIRST DAY OF IMPELLA 5.5 SUPPORT, THE PATIENT HAD ONGOING SEVER HYPOXIA DESPITE ORIGINAL VENOARTERIAL (VA) ECMO AND ALSO HAD LARGE AMOUNTS OF PULMONARY EDEMA FROM ETT. CRRT PLANNED TO BE STARTED TO PULL FLUID. PATIENT ALSO RECEIVED SEVERAL BLOOD PRODUCT SINCE RETURNING FROM THE OR. DURING 5.5 SUPPORT PATIENT WAS TAKEN TO OPERATING ROOM FOR SURGICAL WASHOUT AND CHEST CLOSURE. STROKE AND HYPOXIC ISCHEMIC INJURY WERE DIAGNOSED ON CT IMAGING. PATIENT CONTINUED ON 5.5 SUPPORT FOR SEVERAL DAY, OPERATING WITHIN EXPECTED FLOW RANGES FOR THE SET P-LEVEL, HOWEVER THE PATIENT'S PROGNOSIS DID NOT IMPROVE AND FAMILY WITHDREW CARE. THE DEATH WILL BE CONSERVATIVELY REPORTED ON THE THIRD PUMP, IMPELLA 5.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587650 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. 2026744188 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention| D| L VA EXTRACORPOREAL MEMBRANE OXYGENATION.