BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24911779 · Received April 17, 2026

    Report

    Report Number
    1220648-2026-06925
    Event Type
    Injury
    Date Received
    April 17, 2026
    Date of Event
    April 8, 2026
    Report Date
    May 13, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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. CORRECTED INFORMATION HAS BEEN PROVIDED IN B1(IS PRODUCT PROBLEM); D10(CONCOMITANT MED PRODUCTS). B1: TICKED TO CAPTURE MALFUNCTION PROBLEM. UPON REVIEW, IT WAS IDENTIFIED THAT THE INFORMATION WAS INADVERTENTLY NOT SUBMITTED IN THE INITIAL REPORT. THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. THE CAUSE OF THE POSITIONING ISSUE WAS USE RELATED SINCE THE PATIENT DEVELOPED DELIRIUM AND PULLED OUT THE IMPELLA HIMSELF DURING AN ESCAPE ATTEMPT.

    Additional Manufacturer Narrative · 0

    A01 REMOVED FROM H6; A150202 ADDED. THE INVESTIGATION IS STILL ONGOING.

    Additional Manufacturer Narrative · 0

    A4, A5, AND A6 ARE 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.

    Description of Event or Problem · 0

    IN APRIL 2026 THE GERMAN SOCIETY OF CARDIOLOGY (DGK) HAD THE ANNUAL MEETING AND A PRESENTATION WAS MADE INCLUSIVE OF AN IMPELLA SUPPORT. THE PRESENTATION SPEAKS TO A 42 YEAR OLD MALE PATIENT WHO HAD BEEN TRANSFERRED INTO A TERTIARY MEDICAL CENTER FROM THE COMMUNITY WITH A KNOWN ACUTE MYOCARDIAL INFARCTION AND FAILED ANGIOPLASTY OF THE CORONARY ARTERY IN THE COMMUNITY. THE PATIENT WAS SUPPORTED FIRST BY THE IMPELLA CP AND EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) BUT, THE CARE WAS ESCALATED TO THE IMPELLA 5.5. THE 5.5 AND ECMO STABILIZED THE PATIENT AND THIS ALLOWED FOR THE ECMO TO BE REMOVED AFTER 3 DAYS. WHILE ON THE 5.5 THE PATIENT EXPERIENCED DELIRIUM AND PULLED THE PUMP IN AN "ESCAPE ATTEMPT". THERE WAS NO HARM OR INJURY NOTED FROM THE PATIENT REMOVING THE PUMP FROM THE LEFT VENTRICLE POSITION. THE PRESENTATION STATED THAT AFTER 3 WEEKS OF A HOSPITAL STAY, AND THE 6 WEEK FOLLOWUP THE PATIENT HAD SURVIVED AND WAS IN NYHA CLASS II FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322613 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648

    Patients

    Seq Age Sex Outcome Treatment
    1