BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24482798 · Received March 2, 2026

    Report

    Report Number
    1220648-2026-04319
    Event Type
    Injury
    Date Received
    March 2, 2026
    Date of Event
    February 21, 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
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B1: ADDED PRODUCT PROBLEM, THIS WAS OMITTED IN THE INITIAL IN ERROR.

    Additional Manufacturer Narrative · 0

    THE PUMP HAS BEEN RECEIVED FOR EVALUATION. D9 HAS BEEN UPDATED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED AND D9 HAS BEEN UPDATED TO REFLECT THE DEVICE RECEIPT DATE. INVESTIGATION. AN EVALUATION/ANALYSIS WAS PERFORMED. A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND CONFIRMED THE PUMP PASSED ALL POST STERILE INSPECTION CHECKS. THE CAUSE(S) OF THE REPORTED PRIMING PROBLEM WAS MOST LIKELY AN UNINTENDED USER ERROR AS THE RETURNED PUMP WAS ABLE TO UNDER-GO THE PRIMING PROCESS WITHOUT ISSUE. HEMODYNAMIC INSTABILITY CAUSE WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. H6 COMPONENT CODING AND INVESTIGATION TYPE, FINDINGS AND CONCLUSION CODING HAVE BEEN UPDATED BASED ON THE COMPLETED INVESTIGATION. CORRECTION. D1 BRAND NAME WAS CORRECTED ACCORDINGLY. RELATED REPORT NUMBER. THIS IS ONE OF TWO DEVICE REPORTS ASSOCIATED WITH THE EVENT. REFER TO H10 FOR RELATED REPORT NUMBER(S).

    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

    A (B)(6) YEAR OLD MALE PRESENTED WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, WITH THE PRE SUPPORT CLINICAL CONDITION CONSISTENT WITH SCAI SHOCK STAGE E. DURING PREPARATION FOR IMPELLA CP SUPPORT ON (B)(6) 2026 AT 14:50, THE PURGE SYSTEM WAS UNABLE TO COMPLETE THE SETUP PROCESS. THE INITIAL IMPELLA PUMP EXHIBITED PERSISTENT PURGE SYSTEM SETUP FAILURE THAT WAS NOT RESOLVED BY PURGE CASSETTE OR AIC REPLACEMENT BUT WAS CORRECTED BY FULL PUMP REPLACEMENT. THE SECOND PUMP SUBSEQUENTLY DISPLAYED A SIMILAR FAILURE TO PRIME CONDITION DURING PRIMING. DEVICE RETURN AND EVALUATION ARE REQUIRED TO DETERMINE THE UNDERLYING CAUSE OF THE PURGE SYSTEM FAILURES. THE IMPELLA CP WILL BE CONSERVATIVELY 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
    234485 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027837757 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1