BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24911849 · Received April 17, 2026

    Report

    Report Number
    1220648-2026-06927
    Event Type
    Injury
    Date Received
    April 17, 2026
    Date of Event
    April 9, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS NOT PROVIDED AND SECTION A WAS LEFT BLANK. 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 AN IMPELLA PATIENT WHO SUFFERED A CARDIAC PERFORATION DURING SUPPORT. THE PRESENTATION DID NOT FURNISH PATIENT OR PUMP SPECIFICS, BUT DOES NOTE THAT PERICARDIAL PUNCTURE WITH PIGTAIL WHICH WAS TREATED. THE PATIENT SURVIVED THE EVENT, AND ANGIOGRAPHY NOTED IT TO BE "CONTROLLED". THE CASE IS BEING REPORTED WITH THE MINIMAL DETAILS PROVIDED IN THE SLIDES PRESENTED. CAUSALITY IS NOT KNOWN A THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967176 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention