BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24606872 · Received March 16, 2026

    Report

    Report Number
    1220648-2026-05332
    Event Type
    Injury
    Date Received
    March 16, 2026
    Date of Event
    December 2, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 INVESTIGATION: TYPE, FINDINGS, AND CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. THE CAUSE OF THE PLACEMENT SIGNAL ISSUE CANNOT BE DETERMINED SINCE NO PRODUCT OR DATA LOGS WERE RETURNED AND INSUFFICIENT CLINICAL DETAILS WERE PROVIDED.

    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.

    Additional Manufacturer Narrative · 0

    D1 BRAND NAME, D4 CATALOG NUMBER AND D4 SERIAL NUMBER WERE UPDATED, CORRECTED ACCORDINGLY.

    Description of Event or Problem · 0

    CLINICAL ASSESSMENT: 51 YEAR OLD MALE PATIENT WAS INITIALLY TREATED WITH IMPELLA CP AND ALSO HAD PREVIOUS EXTRACORPOREAL LIFE SUPPORT BEFORE IMPELLA SUPPORT. PATIENT WAS UPGRADED TO IMPELLA 5.5 SUPPORT FOLLOWING NINE DAYS OF IMPELLA CP SUPPORT WHICH WAS BEYOND THE RECOMMENDED DAYS OF SUPPORT FOR THIS PRODUCT IN THE INSTRUCTIONS FOR USE. PATIENT WAS TREATED FOR ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK. THIS COMPLAINT INCIDENT (CI) DEALS WITH THE REPORTING TO THE SECOND IMPELLA 5.5 SUPPORT. ANOTHER CI WAS OPENED FOR THE IMPELLA CP (FIRST PUMP) SUPPORT. FIRST IMPELLA 5.5 INSERTED SUCCESSFULLY USING BEST PRACTICES. 1 -2 HOURS AFTER PROCEDURE, THE PLACEMENT SIGNALS INVERTED AND IMPELLA MAX AND MEAN FLOW WERE NOTED ON 5.5 AS WELL AS PURGE FLOW WAS HIGH AND PURGE PRESSURE. CLINICAL SUPPORT CENTER WAS CONTACTED FOR SECOND OPINION ON PUMP SATURATION , DURING THE CALL THE PROBLEM RESOLVED AND FLOWS WENT DOWN. HEALTH CARE PROFESSIONAL (HCP) MADE DECISION TO EXCHANGE THE PUMP FOR A SECOND IMPELLA 5.5 DEVICE. AFTER TWO WEEKS OF SUPPORT A PURGE FLOW DROP FROM 8ML TO 4ML/HR WAS NOTED AND TROUBLE SHOOTING STEPS INITIATED. CLINICAL SERVICE CENTER CALL TO ADVISE ON RECOMMENDATIONS FOR TISSUE PLASMINOGEN ACTIVATOR RECOMMENDATION, PUT IN CONTACT WITH COMPANY PHYSICIAN ON FURTHER CLARIFICATION OF USAGE OF TISSUE PLASMINOGEN ACTIVATOR (TPA) INFORMATION VIA CLINICAL SUPPORT CENTER, THAT TPA WAS USED. CODED AS THROMBOSIS DUE TO LACK OF FURTHER INFORMATION IN THE CASE FILE. TRANSESOPHAGEAL ECHOCARDIOGRAPHY DONE ON THE DAY OF EXPLANT, SHOWING AORTIC INSUFFICIENCY, WHICH WAS NOT NOTED DURING INITIAL ECHO AT PUMP INSERTION. PATIENT PLANNED FOR VALVE REPAIR BUT IT WAS NOT SPECIFIED IF THIS OCCURRED OR NOT IN THE CASE. - AS NOT SPECIFIED IN CASE, CODED FOR SURGICAL INTERVENTION. PATIENT OVERALL ON SUPPORT FOR MORE THAN SIX WEEKS WITH IMPELLA 5.5 UNTIL SUCCESSFULLY BRIDGED TO LEFT VENTRICULAR ASSIST DEVICE. IMPELLA SUPPORT WAS CONTINUED BEYOND THE RECOMMENDED 14 DAY DURATION PROLONGED USE CAN INCREASE THE RISK OF COMPLICATIONS AND THEREFORE MAY HAVE PLAYED A CONTRIBUTORY ROLE IN THIS ADVERSE EVENT. ENGINEERING ASSESSMENT: PUMP 2: 5.5 PLACEMENT SIGNAL ISSUE LARGE SWINGS IN AORTIC WAVEFORM ARE MOST LIKELY A RESULT OF A PLACEMENT ISSUE. THIS ISSUE WOULD ALSO LEAD TO THE VARIATION OBSERVED IN REPORTED FLOWS SEEN ON THE SCREEN, SINCE THE FLOWS ARE DERIVED USING MOTOR CURRENT AND PLACEMENT SIGNAL. DEVICE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348668 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026725119 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1