BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24686394 · Received March 25, 2026

    Report

    Report Number
    1220648-2026-05898
    Event Type
    Death
    Date Received
    March 25, 2026
    Date of Event
    March 17, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION AND ADDED CLINICAL REVIEW. THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    AN IMPELLA 5.5 DEVICE WAS INSERTED SURGICALLY INTO THE RIGHT AXILLARY/SUBCLAVIAN ARTERY IN A 75-YEAR-OLD MALE PATIENT WITH A PAST MEDICAL HISTORY OF A PRIOR CORONARY ARTERY BYPASS GRAFT (CABG), AND CORONARY ARTERY DISEASE (CAD), PRESENTING IN POST-CARDIOTOMY CARDIOGENIC SHOCK (PCCS) AND LOW CARDIAC OUTPUT SYNDROME (LCOS), IN SCAI STAGE E SHOCK, ON AN INTRA-AORTIC BALLOON PUMP, ON MULTIPLE INOTROPES AND VASOPRESSORS, AND ON A VENTILATOR FOR RESPIRATORY SUPPORT, PRIOR TO INITIATION OF SUPPORT. THE IMPELLA WAS INSERTED FOR VENTRICULAR SUPPORT FOR A CARDIOTHORACIC (CT) SURGERY: CABG. WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), THE PATIENT DEVELOPED A LARGE HEMORRHAGIC STROKE. THE FAMILY WAS AT BEDSIDE TO DETERMINE PLAN OF CARE. MORE THAN ONE MONTH AFTER IMPELLA INSERTION, THE FAMILY WITHDREW CARE, AND THE PATIENT EXPIRED ON SUPPORT. THE IMPELLA FUNCTIONED AT P-8 AT 4.7L/MIN AS INTENDED. HIGH-RISK SURGERIES REQUIRE INTENSE BLOOD THINNERS, INCREASING THE RISK OF BLEEDING. BLEEDING IS ALSO A KNOWN RISK DUE TO THE IMPELLA'S ANTICOAGULATION AND PURGE REQUIREMENTS. HEMORRHAGIC STROKES ARE FREQUENTLY LINKED TO THE NECESSARY USE OF BLOOD THINNERS. THE IMPELLA IS CONSERVATIVELY BEING REPORTED FOR DEATH; HOWEVER, IS UNLIKELY TO HAVE CONTRIBUTED TO THE PATIENT'S DEATH, WHICH WAS MOST LIKELY DUE TO THE CLINICAL CONDITION OF A CRITICALLY ILL PATIENT IN POST-CARDIOTOMY CARDIOGENIC SHOCK AND LOW CARDIAC OUTPUT SYNDROME, COMPLICATED BY STAGE E SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533101 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026798079 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Death