BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24894806 · Received April 16, 2026

    Report

    Report Number
    1220648-2026-06854
    Event Type
    Injury
    Date Received
    April 16, 2026
    Date of Event
    April 12, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT REMAINS ON SUPPORT AT THIS TIME. 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

    THE EXPLANT DATE WAS PROVIDED D6B WAS UPDATED.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA CP WAS INSERTED VIA THE RIGHT FEMORAL PERCUTANEOUS ARTERIAL APPROACH IN A 75-YEAR-OLD MALE PATIENT FOR ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS), PRESENTING IN SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) STAGE E SHOCK. DURING ONGOING IMPELLA CP SUPPORT, HEMOLYSIS WAS IDENTIFIED. IN RESPONSE, THE IMPELLA CP WAS REPOSITIONED UNDER ECHOCARDIOGRAPHIC GUIDANCE. FOLLOWING REPOSITIONING, THE PATIENT'S URINE COLOR WAS NOTED TO BE IMPROVING, BECOMING LIGHTER PINK, AND HEMOLYSIS LABORATORY VALUES CONTINUED TO BE TRENDED. THE PATIENT REMAINED ON IMPELLA CP SUPPORT. HEMOLYSIS IS A KNOWN POTENTIAL RISK ASSOCIATED WITH IMPELLA CP SUPPORT AND MAY BE INFLUENCED BY PATIENT-SPECIFIC FACTORS, INCLUDING SEVERE CARDIOGENIC SHOCK, HEMODYNAMIC INSTABILITY, VENTRICULAR LOADING CONDITIONS, AND DEVICE POSITIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534148 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027839073 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1