BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24500223 · Received March 3, 2026

    Report

    Report Number
    1220648-2026-04425
    Event Type
    Death
    Date Received
    March 3, 2026
    Date of Event
    February 19, 2026
    Report Date
    March 3, 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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5. ADDITIONAL EVENT DESCRIPTION ADDED. D1. BRAND NAME UPDATED.

    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

    THIS COMPLAINT WAS REVIEWED AND DETERMINATION WAS MADE THAT IS NOT A COMPLAINT AS THE BLEEDING OCCURRED BEFORE SHEATH OR PUMP INSERTION.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED REPORTING "IMPELLA SUPPORT WAS THERE AFTER ATTEMPT TO GET ACCESS ON RIGHT GROIN. I AM UNSURED IF THEY USED THE DILATORS AT THAT POINT. I WAS TOLD PROVIDER WAS TRYING TO GET INITIAL ACCESS TO TAKE PICTURES OF RIGHT GROIN AND THEN SWITCHED OVER TO LEFT GROIN BECAUSE VESSELS WERE SMALL AND HEMATOMA WAS FORMING. TO MY UNDERSTANDING, THE PEEL AWAY SHEATH NOR IMPELLA CP WERE IMPLANTED IN RIGHT GROIN."

    Description of Event or Problem · 0

    AN IMPELLA CP WAS INSERTED VIA LEFT FEMORAL ARTERY IN A 80 YEAR OLD MALE WHO WAS ADMITTED FOR HIGH RISK PERCUTANEOUS CORONARY INTERVENTION. THE PATIENT¿S COMORBIDITIES WERE UNKNOWN. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS SCAI STAGE A. DURING THE IMPLANT, PRIOR TO SHEATH USE, RIGHT FEMORAL ACCESS WAS ATTEMPTED BUT UNSUCCESSFUL DUE TO THE PATIENT'S VESSEL BEING TOO SMALL AND TORTUROUS. A SMALL HEMATOMA FORMED AT THE RIGHT GROIN SITE. IT WAS DECIDED TO USE THE LEFT FEMORAL ARTERY AND CP WAS SUCCESSFULLY IMPLANTED. THE RIGHT FEMORAL HEMATOMA WAS GETTING BIGGER DURING THE PROCEDURE AND MANUAL PRESSURE WAS APPLIED. THE PATIENT BEGAN HAVING DIFFICULTY BREATHING, IN WHICH EPINEPHRINE AND LEVOPHED WERE ADMINISTERED AND THE PATIENT WAS INTUBATED. 2 UNITS OF BLOOD WERE ADMINISTERED. THE HEMATOMA WAS REPORTED TO BE LARGE. THE DECISION WAS MADE TO STOP THE HIGH RISK PERCUTANEOUS CORONARY INTERVENTION AND TRANSFER THE PATIENT TO THE INTENSIVE CARE UNIT TO SEE FAMILY BEFORE WITHDRAWING CARE. AFTER TRANSFER TO THE UNIT, CARE WAS WITHDRAWN AND THE PATIENT EXPIRED. VASCULAR INJURY AND DEATH ARE KNOWN RISKS ASSOCIATED WITH IMPELLA CP AS DESCRIBED IN THE INSTRUCTIONS FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289234 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 PUMP 381 PUMP SET (US) 2026813644 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention| D