BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24454302 · Received February 26, 2026

    Report

    Report Number
    1220648-2026-04082
    Event Type
    Death
    Date Received
    February 26, 2026
    Date of Event
    February 12, 2026
    Report Date
    March 24, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A4 IS UNKNOWN. 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. CORRECTED DATA: D1 CORRECTED. THE INVESTIGATION IS STILL ONGOING.

    Additional Manufacturer Narrative · 0

    B1: ADDED PRODUCT PROBLEM, THIS WAS OMITTED IN THE INITIAL IN ERROR.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION WAS PROVIDED IN D3 (MANUFACTURER FAX). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY OMITTED FROM THE INITIAL REPORT. CORRECTED INFORMATION WAS PROVIDED IN D4 (CATALOG). UPON REVIEW, THE SECTION D CATALOG NUMBER HAS NOW BEEN UPDATED. RECAPTURED CODES ON H6 (MEDICAL DEVICE PROBLEM CODE). H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. THE CAUSE OF THE PLACEMENT SIGNAL ISSUE WAS NOT DETERMINED DUE TO LACK OF CLINICAL DETAILS, NO PRODUCT OR DATA LOGS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    AN IMPELLA 5.5 DEVICE WAS INSERTED SURGICALLY INTO THE AORTA IN A 53-YEAR-OLD FEMALE PATIENT WITH A PAST MEDICAL HISTORY OF RENAL INSUFFICIENCY, PRESENTING IN SCAI STAGE B SHOCK, ON A CARDIAC BYPASS, AND ON A VENTILATOR FOR RESPIRATORY SUPPORT, PRIOR TO INITIATION OF SUPPORT. THE IMPELLA WAS INSERTED FOR VENTRICULAR SUPPORT FOR A HIGH-RISK CARDIAC SURGERY: CORONARY ARTERY BYPASS GRAFT (CABG) AND MITRAL VALVE REPLACEMENT. DURING THE PROCEDURE, WHILE THE PHYSICIAN WAS REPOSITIONING THE IMPELLA, THE LEFT VENTRICLE (LV) PERFORATED. SURGICAL REPAIR WAS REQUIRED. IN ADDITION, THERE WAS A PLACEMENT SIGNAL UNRELIABLE ALARM ON THE AUTOMATED IMPELLA CONTROLLER (AIC) CONSOLE SCREEN. PUMP POSITIONING WAS VERIFIED WITH ECHOCARDIOGRAM. WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), THERE WAS AN IMPELLA POSITION UNKNOWN ALARM ON THE AIC, THE AORTIC PRESSURE WAS 135/127, AND NOT CORRELATING WITH THE MEAN ARTERIAL PRESSURE (MAP). THE MOTOR CURRENT (MC) WAS FLAT AT 344/336. THE PUMP WAS NOTED TO BE IN GOOD POSITION WITH IMAGING. EIGHT DAYS AFTER INSERTION, THE FAMILY ELECTED TO WITHDRAW CARE, AND THE PATIENT EXPIRED ON SUPPORT. CARDIAC INJURY (INCLUDING VENTRICULAR PERFORATION) IS LISTED AS A POTENTIAL ADVERSE EVENT, AND CONSISTENT WITH KNOWN DEVICE-RELATED AND PATIENT-RELATED FACTORS DOCUMENTED IN THE INSTRUCTIONS FOR USE (IFU).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567296 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026779310 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1