BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5 WITH SMARTASSIST S2 SET, US

    MDR report key: 24597866 · Received March 13, 2026

    Report

    Report Number
    1220648-2026-05246
    Event Type
    Injury
    Date Received
    March 13, 2026
    Date of Event
    March 7, 2026
    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
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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

    CORRECTED INFORMATION WAS PROVIDED IN D3 (MANUFACTURER FAX). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY OMITTED FROM THE INITIAL REPORT. CORRECTED INFORMATION WAS PROVIDED IN D4 (SERIAL NUMBER). UPON REVIEW, THE SECTION D SERIAL NUMBER HAS NOW BEEN UPDATED. CORRECTED INFORMATION WAS PROVIDED IN E3 (INITIAL REPORTER OCCUPATION). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY SUBMITTED IN ERROR IN THE INITIAL REPORT. H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. THE CAUSE OF THE HIGH PURGE PRESSURE COULD NOT BE DETERMINED AS NO PRODUCT OR LOGS WERE RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    PATIENT WEIGHT AND EXPLANT DATE WERE PROVIDED. A4 AND D6B WERE UPDATED.

    Description of Event or Problem · 0

    CLINICAL RATIONALE: AN IMPELLA 5.5 DEVICE WAS INSERTED SURGICALLY INTO THE RIGHT AXILLARY/SUBCLAVIAN ARTERY IN A 59-YEAR-OLD MALE WITH A PAST MEDICAL HISTORY OF CORONARY ARTERY BYPASS GRAFT (CABG) AND CORONARY ARTERY DISEASE (CAD) PATIENT PRESENTING IN ACUTE MYOCARDIAL INFARCTION (AMI) AND CARDIOGENIC SHOCK (CGS), IN AN OUT-OF-HOSPITAL CARDIAC ARREST REQUIRING CARDIOPULMONARY RESUSCITATION (CPR), IN SCAI STAGE D SHOCK, ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO), ON MULTIPLE INOTROPES AND VASOPRESSORS, AND ON A VENTILATOR FOR RESPIRATORY SUPPORT, PRIOR TO INITIATION OF SUPPORT. THE IMPELLA 5.5 WAS INSERTED AS AN ESCALATION OF THERAPY FROM AN IMPELLA CP. WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), THERE WAS AN ONGOING PURGE PRESSURE (PP) HIGH/PURGE SYSTEM BLOCKED ALARM. TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS INITIATED. THERE WAS NO NOTED INTERRUPTION OF FLOW OR SUPPORT FOR THE PATIENT. IT WAS NOTED THAT THE TPA RESOLVED THE ISSUE. THE POST-PROCEDURE OUTCOME IS UNKNOWN. THE IMPELLA FUNCTIONED AT P-8 AT 4.9L/MIN AS INTENDED. THROMBUS FORMATION CAN CREATE A BLOCKAGE THAT RESTRICTS THE FLOW OF PURGE SOLUTION, AND CAN OCCUR DUE TO INADEQUATE ANTICOAGULATION. THIS IS OFTEN CORRECTED BY USING TPA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484874 IMPELLA 5.5 WITH SMARTASSIST S2 SET, US TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026805559 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1