BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24911740 · Received April 17, 2026

    Report

    Report Number
    1220648-2026-06908
    Event Type
    Injury
    Date Received
    April 17, 2026
    Date of Event
    April 14, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    2026766810
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON COMPLETION OF OUR ANALYSIS, A SUPPLEMENTAL REPORT WILL BE FILED. SECTION D9 HAS BEEN UPDATED.

    Additional Manufacturer Narrative · 0

    SECTION D4 SERIAL NUMBER WAS CORRECTED. SECTION D4 PRIMARY UDI NUMBER HAS BEEN UPDATED. H6 MEDICAL DEVICE PROBLEM CODE A141204 WAS DETERMINED TO BE NO LONGER APPLICABLE TO THIS REPORT AND WAS UPDATED TO A141203.

    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

    CLINICAL NARRATIVE: A 61-YEAR-OLD MALE UNDERWENT IMPELLA CP SUPPORT FOR HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION (HRPCI) WITH A PRE-SUPPORT CLINICAL STATUS CONSISTENT WITH SCAI SHOCK STAGE D. FEMORAL ARTERIAL ACCESS WAS OBTAINED PERCUTANEOUSLY VIA THE RIGHT SIDE. DURING INITIATION OF THE FIRST IMPELLA CP THE PUMP IMMEDIATELY STOPPED WITHIN ONE MINUTE OF ACTIVATION WITH HIGH MOTOR CURRENT ALARMS NOTED. UPWARD TRENDS AND SPIKES IN MOTOR CURRENT WERE OBSERVED, AND AN IMPELLA DEFECTIVE ALARM APPEARED. THROMBUS WAS SUSPECTED BASED ON LEFT VENTRICULAR CURVES AND MOTOR CURRENT; HOWEVER, NO LEFT VENTRICULAR THROMBUS WAS VISUALLY OBSERVED. BIOMATERIAL WAS OBSERVED IN THE OUTFLOW AFTER EXPLANT. PRIOR TO INSERTION, LOSS OF THE EASY GUIDE LUMEN WAS REPORTED, AND THE GUIDEWIRE WAS INSERTED WITHOUT THE EASY GUIDE LUMEN. A TOTAL OF 7,500 IU OF HEPARIN WAS ADMINISTERED INITIALLY WITHOUT ACT MEASUREMENT, FOLLOWED BY AN ADDITIONAL 2,500 IU, AT WHICH TIME ACT WAS 287 SECONDS. THE SHEATH WAS FLUSHED. PUMP RECONNECTION DID NOT RESOLVE THE ISSUE; HOWEVER, THE PUMP WAS ABLE TO BE RESTARTED. DUE TO THE ONGOING ALARM CONDITION AND SUSPECTED FAILURE MODE, THE DEVICE WAS REMOVED APPROXIMATELY 33 MINUTES AFTER IMPLANT, AND THE ISSUE OCCURRED WITHIN THE 24-HOUR THRESHOLD. THE DEVICE WAS REMOVED DUE TO THE FAILURE MODE. A SECOND IMPELLA CP WAS IMPLANTED AND SUBSEQUENTLY SUCCESSFULLY WEANED AFTER A SHORT DURATION OF SUPPORT. THE PATIENT SURVIVED TO EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41595 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026766810 2026766810

    Patients

    Seq Age Sex Outcome Treatment
    1