BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24980025 · Received April 24, 2026

    Report

    Report Number
    1220648-2026-07101
    Event Type
    Injury
    Date Received
    April 24, 2026
    Date of Event
    April 16, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502013276
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4 CATALOG, SERIAL NUMBER AND UDI UPDATED TO REMOVE LEADING 0S. THE INVESTIGATION WAS COMPLETED. INVESTIGATION SUMMARY. PDI (PERIPHERAL ARTERIAL ISCHEMIA): THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    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.

    Description of Event or Problem · 0

    AN IMPELLA 5.5 DEVICE WAS INSERTED VIA THE RIGHT AXILLARY ARTERY IN A 60-YEAR-OLD MALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS). THE PATIENT¿S COMORBIDITIES WERE UNKNOWN. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS IDENTIFIED AS SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) SHOCK STAGE D. LIMB ISCHEMIA DEVELOPED AFTER PUMP IMPLANTATION. VESSEL CONDITIONS INCLUDED TORTUOSITY. ACTIONS TAKEN INCLUDED THROMBECTOMY AND PUMP EXPLANT TO TREAT LIMB ISCHEMIA. THE PATIENT SURVIVED TO EXPLANT. PERIPHERAL ARTERIAL ISCHEMIA MAY OCCUR DUE TO ACCESS-SITE VASCULAR COMPROMISE, VESSEL TORTUOSITY, AND LARGE-BORE ARTERIAL CANNULATION IN THE SETTING OF CRITICAL ILLNESS AND MECHANICAL CIRCULATORY SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591181 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027843039 00813502013276

    Patients

    Seq Age Sex Outcome Treatment
    1