BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24781882 · Received April 3, 2026

    Report

    Report Number
    1220648-2026-06362
    Event Type
    Injury
    Date Received
    April 3, 2026
    Date of Event
    March 27, 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
    TN, US
    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 D3(MANUFACTURER FAX); D4(SERIAL); D10(CONCOMITANT MED PRODUCTS); E1; E3. THE CAUSE OF THE PUMP STOP WAS NOT DETERMINED DUE TO NO PRODUCT RETURNED, NO DATA LOGS RECOVERED, AND INSUFFICIENT CLINICAL DETAILS. THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. PASSED ALL POST STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    THE PUMP WAS DISCARDED. 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

    CLINICAL NARRATIVE: AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY TO SUPPORT THE 38 YEAR OLD MALE PATIENT WHO HAD BEEN ADMITTED IN WITH INDICATION OF ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE E SHOCK. PRIOR TO THE PUMP INSERTION THE PATIENT WAS SUPPORTED BY VA-EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO), INOTROPES, VASOPRESSORS, AND A VENT FOR RESPIRATORY NEEDS. OTHER UNDERLYING MEDICAL HISTORY WAS NOT SHARED. WHEN INSERTING THE CP THE VA-ECMO OXYGENATOR CLOTTED AND WAS REPLACED. ONCE REPLACED THE CP INSERTION CONTINUED. THE PUMP RAN FOR 5 MINUTES AND THEN STOPPED. THE TEAM WAS UNABLE TO RE-START THE CP PUMP AND SO IT WAS REPLACED. THE NEW CP AND VA-ECMO CONTINUE TO SUPPORT THE PATIENT TO DATE. THE REPLACEMENT OF THE STOPPED CP PUMP WILL BE REPORTED FOR HEMODYNAMIC INSTABILITY DUE TO TEMPORARY HEMODYNAMIC SUPPORT INTERRUPTION DURING THE EXCHANGE, HOWEVER THE EXCHANGE WAS PERFORMED WITH NO CONSEQUENCE TO THE PATIENT AND SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150635 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027860098 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1